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Trust
At this ripe point in my career, many new patients come referred by Dr. Google. “I checked the Internet,” they say. “You have great reviews.”
I don’t read my reviews. The abusive ones make me ill. People must filter out the bile and focus on the positives.
Laymen have little sense of how good the professionals they consult really are. Unless I’m audited and lose, how would I know how skillful my accountant is? My urologist is a nice man. How good is he at prostate surgery? I hope not to find out. Nevertheless, reviews are here to stay, as are physician evaluations by insurers and professional agencies.
Some office days highlight the gap, really the chasm, between the truth of the professional matter and what makes patients decide to trust or mistrust us. Last Thursday was one of those days.
Marla brought in her daughter, aged 3 years. Zoe had a scaly rash and some red papules on her arms and legs.
“Did your pediatrician treat this?” I asked.
“No, I came right to you,” said Marla. “You diagnosed her with bedbugs when she was an infant. The pediatricians had no idea what was going on. I trust you.”
That is flattering, but if I were being fully honest, I would tell Marla:
• Bedbug bites are tricky to diagnose. I’ve missed my share.
• What helped me diagnose them in her daughter was that the pediatrician had already tried several remedies that hadn’t helped.
Even if I said these things, though – and why waste all that wonderful transference? – Marla would probably have said, “Maybe so, but you got it right, and I trust you.” Nothing succeeds like success.
The reverse, however, is also true: Nothing fails like failure.
Later the same day Brian brought in Luke, aged 6 years. Luke has severe atopic dermatitis. As usual, he was scratching up a storm. “I think it’s infected,” Brian said. “Shouldn’t he take antibiotics?”
I examined Luke and found subacute eczema. “I don’t think so,” I said. “This is what Luke’s eczema flares look like. Let’s treat him with a topical steroid cream and see how he does.”
“But he had staph last year,” said Brian.
“I recall,” I said, “but most of his outbreaks have not been infected, and it doesn’t look like staph now. Let’s treat it as we usually do and see what happens over the next week.”
Two weeks later Brian brought back Luke, still scratching. There were still no pustules or deeper inflammatory lesions. We started Luke on an antibiotic, and swabbed scratched areas. Two days later the culture grew staph. By the time I called Brian with the results, he had brought Luke to an emergency room. “He has abscesses,” he told me.
The next day the sensitivities were back, confirming staph. I called Brian, who had this to say: “He should have been on antibiotics 2 weeks ago. From now on, whenever he starts scratching, he should be started on them right away. I won’t be bringing him back to your practice. I don’t trust you. I trust the doctors in the ER more.”
Is it really a good idea to start every eczema patient on antibiotics? How about every eczema patient who once had staph? Based on my own clinical experience with both conditions, I would answer both questions in the negative. Others might disagree.
One thing is sure, though: Like most patients, Brian sees the situation not through the eyes of my experience but through his own case series, with an n of 1. But that 1 carries a lot of weight, because the 1 is Luke, his son. It is therefore clear – to him – that his son should be treated preemptively with antibiotics for every eczema flare.
At this point I might too, for Luke, but I will not get the chance. Once trust is gone, the clinical relationship is over. Sometimes it’s one strike and you’re out.
For her part, Marla sees things through her single case report as well, drawing the opposite conclusion: that my success earned me the trust her pediatrician lost.
The subtleties and nuances of such cases, which every clinician knows, are lost in the often black-and-white world of lay reviews and pay-for-performance algorithms. That’s clinical life.
Trust me.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Write to him at [email protected].
At this ripe point in my career, many new patients come referred by Dr. Google. “I checked the Internet,” they say. “You have great reviews.”
I don’t read my reviews. The abusive ones make me ill. People must filter out the bile and focus on the positives.
Laymen have little sense of how good the professionals they consult really are. Unless I’m audited and lose, how would I know how skillful my accountant is? My urologist is a nice man. How good is he at prostate surgery? I hope not to find out. Nevertheless, reviews are here to stay, as are physician evaluations by insurers and professional agencies.
Some office days highlight the gap, really the chasm, between the truth of the professional matter and what makes patients decide to trust or mistrust us. Last Thursday was one of those days.
Marla brought in her daughter, aged 3 years. Zoe had a scaly rash and some red papules on her arms and legs.
“Did your pediatrician treat this?” I asked.
“No, I came right to you,” said Marla. “You diagnosed her with bedbugs when she was an infant. The pediatricians had no idea what was going on. I trust you.”
That is flattering, but if I were being fully honest, I would tell Marla:
• Bedbug bites are tricky to diagnose. I’ve missed my share.
• What helped me diagnose them in her daughter was that the pediatrician had already tried several remedies that hadn’t helped.
Even if I said these things, though – and why waste all that wonderful transference? – Marla would probably have said, “Maybe so, but you got it right, and I trust you.” Nothing succeeds like success.
The reverse, however, is also true: Nothing fails like failure.
Later the same day Brian brought in Luke, aged 6 years. Luke has severe atopic dermatitis. As usual, he was scratching up a storm. “I think it’s infected,” Brian said. “Shouldn’t he take antibiotics?”
I examined Luke and found subacute eczema. “I don’t think so,” I said. “This is what Luke’s eczema flares look like. Let’s treat him with a topical steroid cream and see how he does.”
“But he had staph last year,” said Brian.
“I recall,” I said, “but most of his outbreaks have not been infected, and it doesn’t look like staph now. Let’s treat it as we usually do and see what happens over the next week.”
Two weeks later Brian brought back Luke, still scratching. There were still no pustules or deeper inflammatory lesions. We started Luke on an antibiotic, and swabbed scratched areas. Two days later the culture grew staph. By the time I called Brian with the results, he had brought Luke to an emergency room. “He has abscesses,” he told me.
The next day the sensitivities were back, confirming staph. I called Brian, who had this to say: “He should have been on antibiotics 2 weeks ago. From now on, whenever he starts scratching, he should be started on them right away. I won’t be bringing him back to your practice. I don’t trust you. I trust the doctors in the ER more.”
Is it really a good idea to start every eczema patient on antibiotics? How about every eczema patient who once had staph? Based on my own clinical experience with both conditions, I would answer both questions in the negative. Others might disagree.
One thing is sure, though: Like most patients, Brian sees the situation not through the eyes of my experience but through his own case series, with an n of 1. But that 1 carries a lot of weight, because the 1 is Luke, his son. It is therefore clear – to him – that his son should be treated preemptively with antibiotics for every eczema flare.
At this point I might too, for Luke, but I will not get the chance. Once trust is gone, the clinical relationship is over. Sometimes it’s one strike and you’re out.
For her part, Marla sees things through her single case report as well, drawing the opposite conclusion: that my success earned me the trust her pediatrician lost.
The subtleties and nuances of such cases, which every clinician knows, are lost in the often black-and-white world of lay reviews and pay-for-performance algorithms. That’s clinical life.
Trust me.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Write to him at [email protected].
At this ripe point in my career, many new patients come referred by Dr. Google. “I checked the Internet,” they say. “You have great reviews.”
I don’t read my reviews. The abusive ones make me ill. People must filter out the bile and focus on the positives.
Laymen have little sense of how good the professionals they consult really are. Unless I’m audited and lose, how would I know how skillful my accountant is? My urologist is a nice man. How good is he at prostate surgery? I hope not to find out. Nevertheless, reviews are here to stay, as are physician evaluations by insurers and professional agencies.
Some office days highlight the gap, really the chasm, between the truth of the professional matter and what makes patients decide to trust or mistrust us. Last Thursday was one of those days.
Marla brought in her daughter, aged 3 years. Zoe had a scaly rash and some red papules on her arms and legs.
“Did your pediatrician treat this?” I asked.
“No, I came right to you,” said Marla. “You diagnosed her with bedbugs when she was an infant. The pediatricians had no idea what was going on. I trust you.”
That is flattering, but if I were being fully honest, I would tell Marla:
• Bedbug bites are tricky to diagnose. I’ve missed my share.
• What helped me diagnose them in her daughter was that the pediatrician had already tried several remedies that hadn’t helped.
Even if I said these things, though – and why waste all that wonderful transference? – Marla would probably have said, “Maybe so, but you got it right, and I trust you.” Nothing succeeds like success.
The reverse, however, is also true: Nothing fails like failure.
Later the same day Brian brought in Luke, aged 6 years. Luke has severe atopic dermatitis. As usual, he was scratching up a storm. “I think it’s infected,” Brian said. “Shouldn’t he take antibiotics?”
I examined Luke and found subacute eczema. “I don’t think so,” I said. “This is what Luke’s eczema flares look like. Let’s treat him with a topical steroid cream and see how he does.”
“But he had staph last year,” said Brian.
“I recall,” I said, “but most of his outbreaks have not been infected, and it doesn’t look like staph now. Let’s treat it as we usually do and see what happens over the next week.”
Two weeks later Brian brought back Luke, still scratching. There were still no pustules or deeper inflammatory lesions. We started Luke on an antibiotic, and swabbed scratched areas. Two days later the culture grew staph. By the time I called Brian with the results, he had brought Luke to an emergency room. “He has abscesses,” he told me.
The next day the sensitivities were back, confirming staph. I called Brian, who had this to say: “He should have been on antibiotics 2 weeks ago. From now on, whenever he starts scratching, he should be started on them right away. I won’t be bringing him back to your practice. I don’t trust you. I trust the doctors in the ER more.”
Is it really a good idea to start every eczema patient on antibiotics? How about every eczema patient who once had staph? Based on my own clinical experience with both conditions, I would answer both questions in the negative. Others might disagree.
One thing is sure, though: Like most patients, Brian sees the situation not through the eyes of my experience but through his own case series, with an n of 1. But that 1 carries a lot of weight, because the 1 is Luke, his son. It is therefore clear – to him – that his son should be treated preemptively with antibiotics for every eczema flare.
At this point I might too, for Luke, but I will not get the chance. Once trust is gone, the clinical relationship is over. Sometimes it’s one strike and you’re out.
For her part, Marla sees things through her single case report as well, drawing the opposite conclusion: that my success earned me the trust her pediatrician lost.
The subtleties and nuances of such cases, which every clinician knows, are lost in the often black-and-white world of lay reviews and pay-for-performance algorithms. That’s clinical life.
Trust me.
Dr. Rockoff practices dermatology in Brookline, Mass., and is a longtime contributor to Dermatology News. He serves on the clinical faculty at Tufts University, Boston, and has taught senior medical students and other trainees for 30 years. Write to him at [email protected].
A trip through the history of gynecologic oncology
The subspecialty of gynecologic oncology was formalized less than 50 years ago with the creation of the Society of Gynecologic Oncology and subspecialty training and board certification. The formation of the Gynecologic Oncology Group (GOG) – and the many clinical trials spearheaded by that group – has further advanced evidence-based treatments, resulting in improved survival outcomes, quality of life, and preventive strategies.
While it is not possible to provide a comprehensive and exhaustive review of all of the advances, we hope to highlight many of the notable advances in this article.Cervical cancer
Cervical cancer is the fourth most common cancer in women worldwide with 528,000 new cases in 2012. The majority of cervical cancer cases are caused by infection with human papillomavirus (HPV). While the standard therapies for cervical cancer have been long established (radical hysterectomy for stage I and radiation therapy for locally advanced disease), one of the most significant advances in the past 50 years was the addition of radiation-sensitizing chemotherapy (cisplatin) administered concurrently with radiation therapy.
In randomized trials in both early and advanced cervical cancer, the risk of death was reduced by 30%-50%. These studies changed the paradigm for the treatment of cervical cancer (N Engl J Med. 1999 Apr 15;340[15]:1137-43; N Engl J Med. 1999 Apr 15;340[15]:1144-53; J Clin Oncol. 2000 Apr;18[8]:1606-13).
Future studies evaluating biologic adjuncts or additional chemotherapy are currently underway or awaiting data maturation.
The American Society of Clinical Oncology (ASCO) highlighted the “Top 5 advances in 50 years of Modern Oncology” in 2014, and second on the list was the approval of the HPV vaccine to prevent cervical cancer. Vaccines have been developed that can protect against types 2, 4 or 9 of HPV. In a 2014 study, depending on vaccination coverage, the relative number of cervical cancer cases avoided was 34% in Africa, 27% for America, 26% for Asia, 21% for Europe, and worldwide was estimated at 27% (Vaccine. 2014 Feb 3;32[6]:733-9).
While the benefit from HPV vaccination has been proven, in the United States, only about a third of eligible girls and women have been vaccinated. Efforts should focus on expanding vaccination penetration to eligible girls, boys, women, and men.
Endometrial cancer
Endometrial cancer is the most common gynecologic malignancy in the United States with an estimated 54,870 cases and 10,170 deaths annually. Notable advances in the management of women with endometrial cancer have arisen because of a better understanding that there are two types of endometrial cancer – type I and type II.
The type I endometrial cancers tend to be associated with lower stage of disease at the time of diagnosis and fewer recurrences, while type II endometrial cancer is associated with worse outcomes.
Tailoring the surgical approaches and adjuvant therapy for women with endometrial cancer has led to improved outcomes. The GOG conducted a large prospective randomized trial of laparotomy versus laparoscopic surgical staging for women with clinical early-stage endometrial cancer (LAP2). Laparoscopy was associated with improved perioperative outcomes and was found to be noninferior to laparotomy with regards to survival outcomes (J Clin Oncol. 2012 Mar 1;30[7]:695-700). Therefore, minimally invasive surgery has become widely accepted for the surgical staging of women with endometrial cancer.
Appropriate surgical staging allows for tailoring of postoperative adjuvant therapy. The current evidence suggests that vaginal brachytherapy should be the adjuvant treatment of choice over whole pelvic radiation in women with early-stage endometrial cancer (Lancet. 2010 Mar 6;375[9717]:816-23). Studies are underway to evaluate the role of both adjuvant radiation and chemotherapy in women with early-stage type II endometrial cancer who are felt to be at high risk for recurrent disease, as well as how to improve on the therapeutic options for women with advanced or recurrent disease.
Ovarian cancer
Epithelial ovarian cancer is the most deadly gynecologic malignancy in the United States with 21,290 cases and 14,180 deaths in 2015. The concept of ovarian tumor debulking was first described by Dr. Joe Meigs in 1934, but did not gain traction until the mid-1970s when Dr. C. Thomas Griffiths published his work (Natl Cancer Inst Monogr. 1975 Oct;42:101-4).
While there are no randomized trials proving that surgical cytoreduction improves overall survival, most retrospective studies support this concept. In 2009, Chi et al. showed improved median survival in women with ovarian cancer based on the increased percentage of women who underwent optimal cytoreduction (Gynecol Oncol. 2009 Jul;114[1]:26-31). This has led to modifications of surgical techniques and surgical goals with an effort to maximally cytoreduce all of the visible disease.
While initial surgical debulking is the goal, there are circumstances when a different approach may be indicated. Vergote et al. conducted a prospective randomized trial of 670 women with advanced ovarian cancer. In this study, neoadjuvant chemotherapy followed by interval debulking was not inferior to primary debulking followed by chemotherapy with regards to progression-free survival and overall survival. However, initial surgery was associated with increased surgical complications and perioperative mortality as compared with interval surgery. Therefore, in women who are not felt to be candidates for optimal cytoreduction, neoadjuvant chemotherapy followed by interval surgery may be an appropriate treatment strategy (N Engl J Med. 2010 Sep 2;363[10]:943-53.).
There have been several notable advances and a series of randomized trials – predominately conducted by the GOG – that have resulted in improved overall survival and progression-free interval in women with ovarian cancer. However, none are as significant as the discovery of paclitaxel and platinum-based chemotherapy (cisplatin and carboplatin).
In 1962, samples of the Pacific Yew’s bark were collected and, 2 years later, the extracts from this bark were found to have cytotoxic activity. There were initial difficulties suspending the drug in solution; however, ultimately a formulation in ethanol, cremophor, and saline was found to be effective. In 1984, the National Cancer Institute began clinical trials of paclitaxel and it was found to be highly effective in ovarian cancer. In 1992, it was approved for the treatment of ovarian cancer.
Cisplatin was approved in 1978. Carboplatin entered clinical trials in 1982 and was approved for women with recurrent ovarian cancer in 1989.
There were a series of trials beginning in the late 1980s that established the role of platinum agents and led us to GOG 111. This trial evaluated cisplatin with either cyclophosphamide or paclitaxel. The paclitaxel combination was superior and in 2003 two trials were published that solidified carboplatin and paclitaxel as the cornerstone in the treatment of women with ovarian cancer (J Clin Oncol. 2003 Sep 1;21[17]:3194-200; J Natl Cancer Inst. 2003 Sep 3;95[17]:1320-9).
What has most recently been debated is the route and schedule for both paclitaxel and the platinum agents. In January 2006, the National Cancer Institute released a Clinical Announcement regarding the role of intraperitoneal (IP) chemotherapy for the treatment of women with optimally debulked ovarian cancer. Of the six trials included in the announcement, four trials showed a benefit for progression-free survival and five studies showed an improvement in overall survival. Armstrong et al (GOG 172) showed a 16-month improvement in overall survival with intravenous (IV) paclitaxel, IP cisplatin, and IP paclitaxel. IP chemotherapy has not been universally embraced by physicians and patients in part because of its toxicity, treatment schedule, and the fact that no IP regimen has been compared with the current standard of IV carboplatin and paclitaxel (N Engl J Med. 2006 Jan 5;354[1]:34-43).
While there have been improvements in 5-year survival over time, most women with advanced ovarian cancer will undergo additional chemotherapy in order to achieve subsequent remissions or maintain stability of disease. Other drugs that have Food and Drug Administration approval in the setting of recurrent ovarian cancer include topotecan, liposomal doxorubicin, gemcitabine, bevacizumab, altretamine, carboplatin, cisplatin, cyclophosphamide, and melphalan. Olaparib was recently approved as monotherapy in women with a germline BRCA-mutation who had received three or more prior lines of chemotherapy.
Minimally invasive surgery
Over the last 30 years, minimally invasive surgery (MIS) in gynecologic oncology, particularly for endometrial cancer, has gone from a niche procedure to the standard of care. The introduction of laparoscopy into gynecologic oncology started in the early 1990s. In a series of 59 women undergoing laparoscopy for endometrial cancer, Childers et al. demonstrated feasibility of the technique and low laparotomy conversion rates (Gynecol Oncol. 1993 Oct;51[1]:33-8.). The GOG trial, LAP2, supported the equivalent oncologic outcomes of MIS versus laparotomy for the treatment of endometrial cancer. While many surgeons and centers offered laparoscopic surgery, there were issues with the learning curve that limited its widespread use.
In 2005, the FDA approval of the robotic platform for gynecologic surgery resulted in at least a doubling of the proportion of endometrial cancer patients treated with MIS (Int J Med Robot. 2009 Dec;5[4]:392-7.). In 2012, the Society of Gynecologic Oncology published a consensus statement regarding robotic-assisted surgery in gynecologic oncology (Gynecol Oncol. 2012 Feb;124[2]:180-4.). This review highlights the advantages of the robotics platform with regards to expanding MIS to women with cervical and ovarian cancer; the improvements in outcomes in the obese woman with endometrial cancer; and that the learning curve for robotic surgery is shorter than for traditional laparoscopy. Issues requiring further research include cost analysis as the cost of the new technology decreases, and opportunities for improvement in patient and physician quality of life.
Sentinel node mapping
The rationale for sentinel node mapping is that if one or more sentinel lymph nodes is/are negative for malignancy, then the other regional lymph nodes will also be negative. This would thereby avoid the need for a complete lymph node dissection and its resultant complications, including chronic lymphedema. Much of the work pioneering this strategy has been in breast cancer and melanoma, but data are rapidly emerging for these techniques in gynecologic malignancies.
Candidates for sentinel lymph node biopsy for vulvar cancer include those with a lesion more than 1mm in depth, a tumor less than 4 cm in size, and no obvious metastatic disease on exam or preoperative imaging. Additionally, recommendations have been made regarding case volume in order to achieve limited numbers of false-negative results and to maintain competency. In the study by Van der Zee et al. of 403 patients (623 groins) who underwent sentinel node procedures, the false-negative rate was 0-2%. The overall survival rate was 97% at 3 years (J Clin Oncol. 2008 Feb 20;26[6]:884-9). However, a more recent data from the Gynecologic Oncology Group (GOG 173) showed a slightly higher false-negative rate of 8% (J Clin Oncol. 2012 Nov 1;30[31]:3786-91). Overall survival data are pending from this study.
While sentinel lymph node mapping for endometrial cancer has been feasible for many years and has been well described, the questioned role of completed lymphadenectomy for early-stage endometrial cancer has led to a resurgence of interest in these techniques. While blue dye and radiolabeled tracer methods have historically been the most popular mapping solutions, the advent of endoscopic near-infrared imaging, with its higher sensitivity and good depth penetration, has added options. Indocyanine green fluorescence can be easily detected during robotic surgery and as experience with these techniques increase, successful mapping and sensitivity will increase.
Genetics
While hereditary cancer syndromes have been recognized for many years, detecting the genetic mutations that may increase an individual’s risk of developing a malignancy were not elucidated until the early 1990s. In gynecologic oncology, the most commonly encountered syndromes involve mutations in BRCA1 and BRCA2 and hereditary non–polyposis colorectal cancer, which causes mutations in DNA mismatch-repair genes and increase the risk of endometrial and ovarian cancer.
The SGO recently published a statement on risk assessment for inherited gynecologic cancer predispositions. In this statement “the evaluation for the presence of a hereditary cancer syndrome enables physicians to provide individualized and quantified assessment of cancer risk, as well as options for tailored screening and preventions strategies that may reduce morbidity associated with the development of malignancy” (Gynecol Oncol. 2015 Jan;136[1]:3-7). Beyond risk-reducing salpingo-oophorectomy, therapeutic strategies targeting patients with germline mutations have been developed (PARP inhibitors in BRCA-mutated women with ovarian cancer).
In August 2015, ASCO released an updated policy statement on genetic and genomic testing for cancer susceptibility and highlighted five key areas: germ-line implications of somatic mutation profiling; multigene panel testing for cancer susceptibility; quality assurance in genetic testing; education for oncology professionals; and access to cancer genetic services.
Antiemetics
Rounding out ASCO’s “Top 5 advances in 50 years of Modern Oncology” was the improvement in patients’ quality of life from supportive therapies, in particular antinausea medications.
Several of the agents commonly used in gynecologic oncology rate high (cisplatin) to moderate (carboplatin, cyclophosphamide, doxorubicin, ifosfamide) with regards to emetogenicity. The advent of 5-HT3 receptor antagonists (for example, ondansetron) has significantly improved the quality of life of patients undergoing cytotoxic chemotherapy. In addition to improving quality of life, the decrease in nausea and vomiting can also decrease life-threatening complications such as dehydration and electrolyte imbalance. Both ASCO and the National Comprehensive Cancer Network both have guidelines for the management of nausea and vomiting in patients undergoing chemotherapy.
Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina, Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology at UNC. They reported having no relevant financial disclosures.
The subspecialty of gynecologic oncology was formalized less than 50 years ago with the creation of the Society of Gynecologic Oncology and subspecialty training and board certification. The formation of the Gynecologic Oncology Group (GOG) – and the many clinical trials spearheaded by that group – has further advanced evidence-based treatments, resulting in improved survival outcomes, quality of life, and preventive strategies.
While it is not possible to provide a comprehensive and exhaustive review of all of the advances, we hope to highlight many of the notable advances in this article.Cervical cancer
Cervical cancer is the fourth most common cancer in women worldwide with 528,000 new cases in 2012. The majority of cervical cancer cases are caused by infection with human papillomavirus (HPV). While the standard therapies for cervical cancer have been long established (radical hysterectomy for stage I and radiation therapy for locally advanced disease), one of the most significant advances in the past 50 years was the addition of radiation-sensitizing chemotherapy (cisplatin) administered concurrently with radiation therapy.
In randomized trials in both early and advanced cervical cancer, the risk of death was reduced by 30%-50%. These studies changed the paradigm for the treatment of cervical cancer (N Engl J Med. 1999 Apr 15;340[15]:1137-43; N Engl J Med. 1999 Apr 15;340[15]:1144-53; J Clin Oncol. 2000 Apr;18[8]:1606-13).
Future studies evaluating biologic adjuncts or additional chemotherapy are currently underway or awaiting data maturation.
The American Society of Clinical Oncology (ASCO) highlighted the “Top 5 advances in 50 years of Modern Oncology” in 2014, and second on the list was the approval of the HPV vaccine to prevent cervical cancer. Vaccines have been developed that can protect against types 2, 4 or 9 of HPV. In a 2014 study, depending on vaccination coverage, the relative number of cervical cancer cases avoided was 34% in Africa, 27% for America, 26% for Asia, 21% for Europe, and worldwide was estimated at 27% (Vaccine. 2014 Feb 3;32[6]:733-9).
While the benefit from HPV vaccination has been proven, in the United States, only about a third of eligible girls and women have been vaccinated. Efforts should focus on expanding vaccination penetration to eligible girls, boys, women, and men.
Endometrial cancer
Endometrial cancer is the most common gynecologic malignancy in the United States with an estimated 54,870 cases and 10,170 deaths annually. Notable advances in the management of women with endometrial cancer have arisen because of a better understanding that there are two types of endometrial cancer – type I and type II.
The type I endometrial cancers tend to be associated with lower stage of disease at the time of diagnosis and fewer recurrences, while type II endometrial cancer is associated with worse outcomes.
Tailoring the surgical approaches and adjuvant therapy for women with endometrial cancer has led to improved outcomes. The GOG conducted a large prospective randomized trial of laparotomy versus laparoscopic surgical staging for women with clinical early-stage endometrial cancer (LAP2). Laparoscopy was associated with improved perioperative outcomes and was found to be noninferior to laparotomy with regards to survival outcomes (J Clin Oncol. 2012 Mar 1;30[7]:695-700). Therefore, minimally invasive surgery has become widely accepted for the surgical staging of women with endometrial cancer.
Appropriate surgical staging allows for tailoring of postoperative adjuvant therapy. The current evidence suggests that vaginal brachytherapy should be the adjuvant treatment of choice over whole pelvic radiation in women with early-stage endometrial cancer (Lancet. 2010 Mar 6;375[9717]:816-23). Studies are underway to evaluate the role of both adjuvant radiation and chemotherapy in women with early-stage type II endometrial cancer who are felt to be at high risk for recurrent disease, as well as how to improve on the therapeutic options for women with advanced or recurrent disease.
Ovarian cancer
Epithelial ovarian cancer is the most deadly gynecologic malignancy in the United States with 21,290 cases and 14,180 deaths in 2015. The concept of ovarian tumor debulking was first described by Dr. Joe Meigs in 1934, but did not gain traction until the mid-1970s when Dr. C. Thomas Griffiths published his work (Natl Cancer Inst Monogr. 1975 Oct;42:101-4).
While there are no randomized trials proving that surgical cytoreduction improves overall survival, most retrospective studies support this concept. In 2009, Chi et al. showed improved median survival in women with ovarian cancer based on the increased percentage of women who underwent optimal cytoreduction (Gynecol Oncol. 2009 Jul;114[1]:26-31). This has led to modifications of surgical techniques and surgical goals with an effort to maximally cytoreduce all of the visible disease.
While initial surgical debulking is the goal, there are circumstances when a different approach may be indicated. Vergote et al. conducted a prospective randomized trial of 670 women with advanced ovarian cancer. In this study, neoadjuvant chemotherapy followed by interval debulking was not inferior to primary debulking followed by chemotherapy with regards to progression-free survival and overall survival. However, initial surgery was associated with increased surgical complications and perioperative mortality as compared with interval surgery. Therefore, in women who are not felt to be candidates for optimal cytoreduction, neoadjuvant chemotherapy followed by interval surgery may be an appropriate treatment strategy (N Engl J Med. 2010 Sep 2;363[10]:943-53.).
There have been several notable advances and a series of randomized trials – predominately conducted by the GOG – that have resulted in improved overall survival and progression-free interval in women with ovarian cancer. However, none are as significant as the discovery of paclitaxel and platinum-based chemotherapy (cisplatin and carboplatin).
In 1962, samples of the Pacific Yew’s bark were collected and, 2 years later, the extracts from this bark were found to have cytotoxic activity. There were initial difficulties suspending the drug in solution; however, ultimately a formulation in ethanol, cremophor, and saline was found to be effective. In 1984, the National Cancer Institute began clinical trials of paclitaxel and it was found to be highly effective in ovarian cancer. In 1992, it was approved for the treatment of ovarian cancer.
Cisplatin was approved in 1978. Carboplatin entered clinical trials in 1982 and was approved for women with recurrent ovarian cancer in 1989.
There were a series of trials beginning in the late 1980s that established the role of platinum agents and led us to GOG 111. This trial evaluated cisplatin with either cyclophosphamide or paclitaxel. The paclitaxel combination was superior and in 2003 two trials were published that solidified carboplatin and paclitaxel as the cornerstone in the treatment of women with ovarian cancer (J Clin Oncol. 2003 Sep 1;21[17]:3194-200; J Natl Cancer Inst. 2003 Sep 3;95[17]:1320-9).
What has most recently been debated is the route and schedule for both paclitaxel and the platinum agents. In January 2006, the National Cancer Institute released a Clinical Announcement regarding the role of intraperitoneal (IP) chemotherapy for the treatment of women with optimally debulked ovarian cancer. Of the six trials included in the announcement, four trials showed a benefit for progression-free survival and five studies showed an improvement in overall survival. Armstrong et al (GOG 172) showed a 16-month improvement in overall survival with intravenous (IV) paclitaxel, IP cisplatin, and IP paclitaxel. IP chemotherapy has not been universally embraced by physicians and patients in part because of its toxicity, treatment schedule, and the fact that no IP regimen has been compared with the current standard of IV carboplatin and paclitaxel (N Engl J Med. 2006 Jan 5;354[1]:34-43).
While there have been improvements in 5-year survival over time, most women with advanced ovarian cancer will undergo additional chemotherapy in order to achieve subsequent remissions or maintain stability of disease. Other drugs that have Food and Drug Administration approval in the setting of recurrent ovarian cancer include topotecan, liposomal doxorubicin, gemcitabine, bevacizumab, altretamine, carboplatin, cisplatin, cyclophosphamide, and melphalan. Olaparib was recently approved as monotherapy in women with a germline BRCA-mutation who had received three or more prior lines of chemotherapy.
Minimally invasive surgery
Over the last 30 years, minimally invasive surgery (MIS) in gynecologic oncology, particularly for endometrial cancer, has gone from a niche procedure to the standard of care. The introduction of laparoscopy into gynecologic oncology started in the early 1990s. In a series of 59 women undergoing laparoscopy for endometrial cancer, Childers et al. demonstrated feasibility of the technique and low laparotomy conversion rates (Gynecol Oncol. 1993 Oct;51[1]:33-8.). The GOG trial, LAP2, supported the equivalent oncologic outcomes of MIS versus laparotomy for the treatment of endometrial cancer. While many surgeons and centers offered laparoscopic surgery, there were issues with the learning curve that limited its widespread use.
In 2005, the FDA approval of the robotic platform for gynecologic surgery resulted in at least a doubling of the proportion of endometrial cancer patients treated with MIS (Int J Med Robot. 2009 Dec;5[4]:392-7.). In 2012, the Society of Gynecologic Oncology published a consensus statement regarding robotic-assisted surgery in gynecologic oncology (Gynecol Oncol. 2012 Feb;124[2]:180-4.). This review highlights the advantages of the robotics platform with regards to expanding MIS to women with cervical and ovarian cancer; the improvements in outcomes in the obese woman with endometrial cancer; and that the learning curve for robotic surgery is shorter than for traditional laparoscopy. Issues requiring further research include cost analysis as the cost of the new technology decreases, and opportunities for improvement in patient and physician quality of life.
Sentinel node mapping
The rationale for sentinel node mapping is that if one or more sentinel lymph nodes is/are negative for malignancy, then the other regional lymph nodes will also be negative. This would thereby avoid the need for a complete lymph node dissection and its resultant complications, including chronic lymphedema. Much of the work pioneering this strategy has been in breast cancer and melanoma, but data are rapidly emerging for these techniques in gynecologic malignancies.
Candidates for sentinel lymph node biopsy for vulvar cancer include those with a lesion more than 1mm in depth, a tumor less than 4 cm in size, and no obvious metastatic disease on exam or preoperative imaging. Additionally, recommendations have been made regarding case volume in order to achieve limited numbers of false-negative results and to maintain competency. In the study by Van der Zee et al. of 403 patients (623 groins) who underwent sentinel node procedures, the false-negative rate was 0-2%. The overall survival rate was 97% at 3 years (J Clin Oncol. 2008 Feb 20;26[6]:884-9). However, a more recent data from the Gynecologic Oncology Group (GOG 173) showed a slightly higher false-negative rate of 8% (J Clin Oncol. 2012 Nov 1;30[31]:3786-91). Overall survival data are pending from this study.
While sentinel lymph node mapping for endometrial cancer has been feasible for many years and has been well described, the questioned role of completed lymphadenectomy for early-stage endometrial cancer has led to a resurgence of interest in these techniques. While blue dye and radiolabeled tracer methods have historically been the most popular mapping solutions, the advent of endoscopic near-infrared imaging, with its higher sensitivity and good depth penetration, has added options. Indocyanine green fluorescence can be easily detected during robotic surgery and as experience with these techniques increase, successful mapping and sensitivity will increase.
Genetics
While hereditary cancer syndromes have been recognized for many years, detecting the genetic mutations that may increase an individual’s risk of developing a malignancy were not elucidated until the early 1990s. In gynecologic oncology, the most commonly encountered syndromes involve mutations in BRCA1 and BRCA2 and hereditary non–polyposis colorectal cancer, which causes mutations in DNA mismatch-repair genes and increase the risk of endometrial and ovarian cancer.
The SGO recently published a statement on risk assessment for inherited gynecologic cancer predispositions. In this statement “the evaluation for the presence of a hereditary cancer syndrome enables physicians to provide individualized and quantified assessment of cancer risk, as well as options for tailored screening and preventions strategies that may reduce morbidity associated with the development of malignancy” (Gynecol Oncol. 2015 Jan;136[1]:3-7). Beyond risk-reducing salpingo-oophorectomy, therapeutic strategies targeting patients with germline mutations have been developed (PARP inhibitors in BRCA-mutated women with ovarian cancer).
In August 2015, ASCO released an updated policy statement on genetic and genomic testing for cancer susceptibility and highlighted five key areas: germ-line implications of somatic mutation profiling; multigene panel testing for cancer susceptibility; quality assurance in genetic testing; education for oncology professionals; and access to cancer genetic services.
Antiemetics
Rounding out ASCO’s “Top 5 advances in 50 years of Modern Oncology” was the improvement in patients’ quality of life from supportive therapies, in particular antinausea medications.
Several of the agents commonly used in gynecologic oncology rate high (cisplatin) to moderate (carboplatin, cyclophosphamide, doxorubicin, ifosfamide) with regards to emetogenicity. The advent of 5-HT3 receptor antagonists (for example, ondansetron) has significantly improved the quality of life of patients undergoing cytotoxic chemotherapy. In addition to improving quality of life, the decrease in nausea and vomiting can also decrease life-threatening complications such as dehydration and electrolyte imbalance. Both ASCO and the National Comprehensive Cancer Network both have guidelines for the management of nausea and vomiting in patients undergoing chemotherapy.
Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina, Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology at UNC. They reported having no relevant financial disclosures.
The subspecialty of gynecologic oncology was formalized less than 50 years ago with the creation of the Society of Gynecologic Oncology and subspecialty training and board certification. The formation of the Gynecologic Oncology Group (GOG) – and the many clinical trials spearheaded by that group – has further advanced evidence-based treatments, resulting in improved survival outcomes, quality of life, and preventive strategies.
While it is not possible to provide a comprehensive and exhaustive review of all of the advances, we hope to highlight many of the notable advances in this article.Cervical cancer
Cervical cancer is the fourth most common cancer in women worldwide with 528,000 new cases in 2012. The majority of cervical cancer cases are caused by infection with human papillomavirus (HPV). While the standard therapies for cervical cancer have been long established (radical hysterectomy for stage I and radiation therapy for locally advanced disease), one of the most significant advances in the past 50 years was the addition of radiation-sensitizing chemotherapy (cisplatin) administered concurrently with radiation therapy.
In randomized trials in both early and advanced cervical cancer, the risk of death was reduced by 30%-50%. These studies changed the paradigm for the treatment of cervical cancer (N Engl J Med. 1999 Apr 15;340[15]:1137-43; N Engl J Med. 1999 Apr 15;340[15]:1144-53; J Clin Oncol. 2000 Apr;18[8]:1606-13).
Future studies evaluating biologic adjuncts or additional chemotherapy are currently underway or awaiting data maturation.
The American Society of Clinical Oncology (ASCO) highlighted the “Top 5 advances in 50 years of Modern Oncology” in 2014, and second on the list was the approval of the HPV vaccine to prevent cervical cancer. Vaccines have been developed that can protect against types 2, 4 or 9 of HPV. In a 2014 study, depending on vaccination coverage, the relative number of cervical cancer cases avoided was 34% in Africa, 27% for America, 26% for Asia, 21% for Europe, and worldwide was estimated at 27% (Vaccine. 2014 Feb 3;32[6]:733-9).
While the benefit from HPV vaccination has been proven, in the United States, only about a third of eligible girls and women have been vaccinated. Efforts should focus on expanding vaccination penetration to eligible girls, boys, women, and men.
Endometrial cancer
Endometrial cancer is the most common gynecologic malignancy in the United States with an estimated 54,870 cases and 10,170 deaths annually. Notable advances in the management of women with endometrial cancer have arisen because of a better understanding that there are two types of endometrial cancer – type I and type II.
The type I endometrial cancers tend to be associated with lower stage of disease at the time of diagnosis and fewer recurrences, while type II endometrial cancer is associated with worse outcomes.
Tailoring the surgical approaches and adjuvant therapy for women with endometrial cancer has led to improved outcomes. The GOG conducted a large prospective randomized trial of laparotomy versus laparoscopic surgical staging for women with clinical early-stage endometrial cancer (LAP2). Laparoscopy was associated with improved perioperative outcomes and was found to be noninferior to laparotomy with regards to survival outcomes (J Clin Oncol. 2012 Mar 1;30[7]:695-700). Therefore, minimally invasive surgery has become widely accepted for the surgical staging of women with endometrial cancer.
Appropriate surgical staging allows for tailoring of postoperative adjuvant therapy. The current evidence suggests that vaginal brachytherapy should be the adjuvant treatment of choice over whole pelvic radiation in women with early-stage endometrial cancer (Lancet. 2010 Mar 6;375[9717]:816-23). Studies are underway to evaluate the role of both adjuvant radiation and chemotherapy in women with early-stage type II endometrial cancer who are felt to be at high risk for recurrent disease, as well as how to improve on the therapeutic options for women with advanced or recurrent disease.
Ovarian cancer
Epithelial ovarian cancer is the most deadly gynecologic malignancy in the United States with 21,290 cases and 14,180 deaths in 2015. The concept of ovarian tumor debulking was first described by Dr. Joe Meigs in 1934, but did not gain traction until the mid-1970s when Dr. C. Thomas Griffiths published his work (Natl Cancer Inst Monogr. 1975 Oct;42:101-4).
While there are no randomized trials proving that surgical cytoreduction improves overall survival, most retrospective studies support this concept. In 2009, Chi et al. showed improved median survival in women with ovarian cancer based on the increased percentage of women who underwent optimal cytoreduction (Gynecol Oncol. 2009 Jul;114[1]:26-31). This has led to modifications of surgical techniques and surgical goals with an effort to maximally cytoreduce all of the visible disease.
While initial surgical debulking is the goal, there are circumstances when a different approach may be indicated. Vergote et al. conducted a prospective randomized trial of 670 women with advanced ovarian cancer. In this study, neoadjuvant chemotherapy followed by interval debulking was not inferior to primary debulking followed by chemotherapy with regards to progression-free survival and overall survival. However, initial surgery was associated with increased surgical complications and perioperative mortality as compared with interval surgery. Therefore, in women who are not felt to be candidates for optimal cytoreduction, neoadjuvant chemotherapy followed by interval surgery may be an appropriate treatment strategy (N Engl J Med. 2010 Sep 2;363[10]:943-53.).
There have been several notable advances and a series of randomized trials – predominately conducted by the GOG – that have resulted in improved overall survival and progression-free interval in women with ovarian cancer. However, none are as significant as the discovery of paclitaxel and platinum-based chemotherapy (cisplatin and carboplatin).
In 1962, samples of the Pacific Yew’s bark were collected and, 2 years later, the extracts from this bark were found to have cytotoxic activity. There were initial difficulties suspending the drug in solution; however, ultimately a formulation in ethanol, cremophor, and saline was found to be effective. In 1984, the National Cancer Institute began clinical trials of paclitaxel and it was found to be highly effective in ovarian cancer. In 1992, it was approved for the treatment of ovarian cancer.
Cisplatin was approved in 1978. Carboplatin entered clinical trials in 1982 and was approved for women with recurrent ovarian cancer in 1989.
There were a series of trials beginning in the late 1980s that established the role of platinum agents and led us to GOG 111. This trial evaluated cisplatin with either cyclophosphamide or paclitaxel. The paclitaxel combination was superior and in 2003 two trials were published that solidified carboplatin and paclitaxel as the cornerstone in the treatment of women with ovarian cancer (J Clin Oncol. 2003 Sep 1;21[17]:3194-200; J Natl Cancer Inst. 2003 Sep 3;95[17]:1320-9).
What has most recently been debated is the route and schedule for both paclitaxel and the platinum agents. In January 2006, the National Cancer Institute released a Clinical Announcement regarding the role of intraperitoneal (IP) chemotherapy for the treatment of women with optimally debulked ovarian cancer. Of the six trials included in the announcement, four trials showed a benefit for progression-free survival and five studies showed an improvement in overall survival. Armstrong et al (GOG 172) showed a 16-month improvement in overall survival with intravenous (IV) paclitaxel, IP cisplatin, and IP paclitaxel. IP chemotherapy has not been universally embraced by physicians and patients in part because of its toxicity, treatment schedule, and the fact that no IP regimen has been compared with the current standard of IV carboplatin and paclitaxel (N Engl J Med. 2006 Jan 5;354[1]:34-43).
While there have been improvements in 5-year survival over time, most women with advanced ovarian cancer will undergo additional chemotherapy in order to achieve subsequent remissions or maintain stability of disease. Other drugs that have Food and Drug Administration approval in the setting of recurrent ovarian cancer include topotecan, liposomal doxorubicin, gemcitabine, bevacizumab, altretamine, carboplatin, cisplatin, cyclophosphamide, and melphalan. Olaparib was recently approved as monotherapy in women with a germline BRCA-mutation who had received three or more prior lines of chemotherapy.
Minimally invasive surgery
Over the last 30 years, minimally invasive surgery (MIS) in gynecologic oncology, particularly for endometrial cancer, has gone from a niche procedure to the standard of care. The introduction of laparoscopy into gynecologic oncology started in the early 1990s. In a series of 59 women undergoing laparoscopy for endometrial cancer, Childers et al. demonstrated feasibility of the technique and low laparotomy conversion rates (Gynecol Oncol. 1993 Oct;51[1]:33-8.). The GOG trial, LAP2, supported the equivalent oncologic outcomes of MIS versus laparotomy for the treatment of endometrial cancer. While many surgeons and centers offered laparoscopic surgery, there were issues with the learning curve that limited its widespread use.
In 2005, the FDA approval of the robotic platform for gynecologic surgery resulted in at least a doubling of the proportion of endometrial cancer patients treated with MIS (Int J Med Robot. 2009 Dec;5[4]:392-7.). In 2012, the Society of Gynecologic Oncology published a consensus statement regarding robotic-assisted surgery in gynecologic oncology (Gynecol Oncol. 2012 Feb;124[2]:180-4.). This review highlights the advantages of the robotics platform with regards to expanding MIS to women with cervical and ovarian cancer; the improvements in outcomes in the obese woman with endometrial cancer; and that the learning curve for robotic surgery is shorter than for traditional laparoscopy. Issues requiring further research include cost analysis as the cost of the new technology decreases, and opportunities for improvement in patient and physician quality of life.
Sentinel node mapping
The rationale for sentinel node mapping is that if one or more sentinel lymph nodes is/are negative for malignancy, then the other regional lymph nodes will also be negative. This would thereby avoid the need for a complete lymph node dissection and its resultant complications, including chronic lymphedema. Much of the work pioneering this strategy has been in breast cancer and melanoma, but data are rapidly emerging for these techniques in gynecologic malignancies.
Candidates for sentinel lymph node biopsy for vulvar cancer include those with a lesion more than 1mm in depth, a tumor less than 4 cm in size, and no obvious metastatic disease on exam or preoperative imaging. Additionally, recommendations have been made regarding case volume in order to achieve limited numbers of false-negative results and to maintain competency. In the study by Van der Zee et al. of 403 patients (623 groins) who underwent sentinel node procedures, the false-negative rate was 0-2%. The overall survival rate was 97% at 3 years (J Clin Oncol. 2008 Feb 20;26[6]:884-9). However, a more recent data from the Gynecologic Oncology Group (GOG 173) showed a slightly higher false-negative rate of 8% (J Clin Oncol. 2012 Nov 1;30[31]:3786-91). Overall survival data are pending from this study.
While sentinel lymph node mapping for endometrial cancer has been feasible for many years and has been well described, the questioned role of completed lymphadenectomy for early-stage endometrial cancer has led to a resurgence of interest in these techniques. While blue dye and radiolabeled tracer methods have historically been the most popular mapping solutions, the advent of endoscopic near-infrared imaging, with its higher sensitivity and good depth penetration, has added options. Indocyanine green fluorescence can be easily detected during robotic surgery and as experience with these techniques increase, successful mapping and sensitivity will increase.
Genetics
While hereditary cancer syndromes have been recognized for many years, detecting the genetic mutations that may increase an individual’s risk of developing a malignancy were not elucidated until the early 1990s. In gynecologic oncology, the most commonly encountered syndromes involve mutations in BRCA1 and BRCA2 and hereditary non–polyposis colorectal cancer, which causes mutations in DNA mismatch-repair genes and increase the risk of endometrial and ovarian cancer.
The SGO recently published a statement on risk assessment for inherited gynecologic cancer predispositions. In this statement “the evaluation for the presence of a hereditary cancer syndrome enables physicians to provide individualized and quantified assessment of cancer risk, as well as options for tailored screening and preventions strategies that may reduce morbidity associated with the development of malignancy” (Gynecol Oncol. 2015 Jan;136[1]:3-7). Beyond risk-reducing salpingo-oophorectomy, therapeutic strategies targeting patients with germline mutations have been developed (PARP inhibitors in BRCA-mutated women with ovarian cancer).
In August 2015, ASCO released an updated policy statement on genetic and genomic testing for cancer susceptibility and highlighted five key areas: germ-line implications of somatic mutation profiling; multigene panel testing for cancer susceptibility; quality assurance in genetic testing; education for oncology professionals; and access to cancer genetic services.
Antiemetics
Rounding out ASCO’s “Top 5 advances in 50 years of Modern Oncology” was the improvement in patients’ quality of life from supportive therapies, in particular antinausea medications.
Several of the agents commonly used in gynecologic oncology rate high (cisplatin) to moderate (carboplatin, cyclophosphamide, doxorubicin, ifosfamide) with regards to emetogenicity. The advent of 5-HT3 receptor antagonists (for example, ondansetron) has significantly improved the quality of life of patients undergoing cytotoxic chemotherapy. In addition to improving quality of life, the decrease in nausea and vomiting can also decrease life-threatening complications such as dehydration and electrolyte imbalance. Both ASCO and the National Comprehensive Cancer Network both have guidelines for the management of nausea and vomiting in patients undergoing chemotherapy.
Throughout 2016, Ob.Gyn. News will celebrate its 50th anniversary with exclusive articles looking at the evolution of the specialty, including the history of contraception, changes in gynecologic surgery, and the transformation of the well-woman visit. Look for these articles and more special features in the pages of Ob.Gyn. News and online at obgynnews.com.
Dr. Gehrig is professor and director of gynecologic oncology at the University of North Carolina, Chapel Hill. Dr. Clarke-Pearson is the chair and the Robert A. Ross Distinguished Professor of Obstetrics and Gynecology, and a professor in the division of gynecologic oncology at UNC. They reported having no relevant financial disclosures.
Sports Medicine Fellowship: What Should I Be Looking For?
The Orthopaedic Sports Medicine Fellowship Match was first established in 2008 as a joint-sponsored venture between the American Orthopaedic Society for Sports Medicine and the Arthroscopy Association of North America to pair applicants with participating training programs.1 Operated under the San Francisco Match,2 the current fellowship match process was adopted to systematically coordinate training appointments and eliminate the role of “exploding offers,” which are pressured early decisions predicated on immediate acceptance. Other advantages of this system include its operation through a central application service to avoid redundancy of submitted paperwork, as well as to create greater awareness and to publicize training options and standardization of the match timeline.1
In its current state, the orthopedic sports medicine match represents 96 programs with 230 positions, accounting for approximately 97% of training programs and fellowship positions.1 While unaccredited options remain available through the Match, many programs have migrated towards American Council for Graduate Medical Education (ACGME) accreditation because of an increased focus on objective learning metrics during fellowship and the requirement for Subspecialty Certification in Orthopaedic Sports Medicine through the American Board of Orthopaedic Surgery.3 However, other programs have also eschewed the increasing constraints and administrative resources associated with ACGME accreditation, particularly among fellowships based at community-based hospitals or private practices that lack formal affiliation with academic institutions or residency training programs.
Along with a greater understanding of the historical background of the match process, fellowship applicants must also appreciate the relative merits of fellowship training. More than 90% of orthopedic surgery residents now pursue further subspecialty fellowship training, with some individuals opting for 2 additional fellowship opportunities.4 As a so-called “nontraditional applicant,” I represent a different demographic, returning to fellowship after years of clinical practice while serving in the military. Individual preferences notwithstanding, I wanted to take the opportunity to emphasize some important considerations in deliberating between different fellowship programs.
- Geography. Your eventual desired practice location may play a role in determining fellowship location or, at least, region of the country. Additionally, this can be an important factor in family happiness. In competitive markets, such as the Northeast or the West Coast, you may make inroads and establish professional connections that result in potential job opportunities. Conversely, other programs may adopt anticompetitive measures to limit local practice options.
- Training setting. Despite the trending consolidation of fellowship training programs in affiliated university and hospital-based teaching systems, many community-based programs and private-practice models thrive, providing an alternative to traditional academic training centers. The latter may provide more in-depth exposure to practice management, billing/coding, and ancillary services. The former typically offer a more structured, academically oriented environment with formal teaching conferences and a broader department hierarchy.
- Program size. Some applicants may prefer a larger, more diverse array of teaching staff or fellows, while others gravitate toward fewer, more personal mentoring relationships that allow more intimate familiarity with practice habits or surgical techniques.
- Associated training programs. Affiliations with a residency or physician-extender training program can offer benefits and drawbacks, including offloading clerical work, shared hands-on experience in the clinic and operating room, and midlevel supervisory responsibilities. This can offer useful opportunities to formulate an individual teaching style and valuable mentoring relationships. However, it can also impose greater time requirements or detract from one-on-one teaching with staff.
- Reputation. Applicants may attach distinction to a well-established regional or national reputation associated with a given training program. Often, certain programs may carry prestige as a result of their academic name, hospital affiliation, or accomplishments. This can offer certain marketing advantages for patient recruitment. However, less renowned programs may provide better training opportunities and confer higher esteem among your professional colleagues. Program reputation can change dramatically with time, so this should be balanced with other potential strengths and overall training experience.
- Practice “niches”/areas of interest. With increasing adoption of arthroscopic techniques among practicing surgeons and a relative excess of sports medicine–trained orthopedists, it is paramount to develop a novel skill set during fellowship to differentiate you from other graduates. I sought a sports medicine fellowship that would offer me a broad-based exposure to arthroscopic and open knee and shoulder reconstruction, chondral restoration techniques, hip arthroscopy and preservation, and shoulder arthroplasty. Opportunities in elbow reconstruction, foot and ankle arthroscopy, and pediatric sports medicine may also be valuable as a distinguishing factor in searching for jobs after training.
- Marketability. Closely intertwined with reputation and scope of practice, an institution’s marketability is another intangible attribute to consider. Professional or collegiate team coverage offers significant market value for patient advertising, and it is frequently publicized by orthopedic practices and hospital systems. Additionally, the importance of ACGME accreditation should also be considered.
- Nonmedical training. This is increasingly important in subsequent subspecialty training. Further education on the business aspects of orthopedic surgery should be emphasized. Additionally, dedicated curricula on professional or leadership development are important for career progression.
- Mentorship. Throughout the interview process, one of my foremost priorities was a strong and enduring pattern of mentorship. Fellowship offers the opportunity to establish 1 or multiple mentors in your subspecialty. These individuals will be instrumental in the development of your early professional career and your approach to clinical practice. From discussions about complicated patients to advice on contract negotiations, your ideal mentor should champion your early successes and work generously on your behalf, even long after fellowship has ended.
- Research opportunities. Given my academic career goals, I actively pursued a program with rich clinical and laboratory resources, and an established infrastructure for accomplishing high-quality, relevant research. Interested individuals should gauge the availability of research support staff, biomechanical or bench-level laboratory collaboration, grant or institutional research funding, cadaveric specimens, or clinical outcomes data for research conducted by fellows. However, not all fellowship applicants have a vested interest in research during fellowship, so I would encourage inquiries regarding core research requirements and expectations.
- Clinical exposure. This encompasses several different and equally important variables, including diversity of clinical or surgical caseloads, case complexity, operative exposure, athletic team coverage, and office or clinical experience. Interestingly, this latter aspect of training is often neglected but cannot be overemphasized. Outpatient clinical evaluation is key to honing important physical examination techniques and critically evaluating patients’ outcomes postoperatively.
- Surgical autonomy. Hands-on operative experience and surgical autonomy vary widely among fellowship programs. Most fellowships advocate for a graduated level of surgical responsibility dependent on individual abilities and staff comfort, while others offer greater potential for independence. Conversely, some programs espouse more of an “observership” model, and arthroscopic simulators and/or cadaveric skills laboratories are designed to complement operative experience. While most fellowship applicants desire maximal case participation, we must also recognize the value in watching talented surgeons performing technically demanding procedures.
- Family. You cannot put a premium on your personal contentment and family’s well-being. Proximity to a support network can be important with the work demands and time constraints of fellowship.
Despite financial obligations and significant time commitments, the fellowship match process offers an incredible range of programs and practice environments. Inevitably, no program can completely fulfill all your criteria, but you should be able to tailor your learning style, professional ambitions, and personal preferences with an excellent training program. For many, fellowship represents the last, and perhaps most integral, stage of formal surgical training. Considering all factors of your chosen fellowship program will ensure a rich and fulfilling educational experience.
1. Sports medicine/arthroscopy fellowship match. American Orthopaedic Society for Sports Medicine website. https://www.sportsmed.org/AOSSMIMIS/Members/Members/Education/Sports_Medicine_Arthroscopy_Fellowship_Match.aspx. Accessed December 21, 2015.
2. Orthopaedic sports medicine fellowship. SF Match website. https://www.sfmatch.org/SpecialtyInsideAll.aspx?id=11&typ=1&name=Orthopaedic%20Sports%20Medicine. Accessed December 21, 2015.
3. Orthopaedic sports medicine. American Board of Orthopaedic Surgery website. https://www.abos.org/certification/sports-subspecialty.aspx. Accessed December 21, 2015.
4. Hariri S, York SC, O’Connor MI, Parsley BS, McCarthy JC. Career plans of current orthopaedic residents with a focus on sex-based and generational differences. J Bone Joint Surg Am. 2011;93(5):e16.
The Orthopaedic Sports Medicine Fellowship Match was first established in 2008 as a joint-sponsored venture between the American Orthopaedic Society for Sports Medicine and the Arthroscopy Association of North America to pair applicants with participating training programs.1 Operated under the San Francisco Match,2 the current fellowship match process was adopted to systematically coordinate training appointments and eliminate the role of “exploding offers,” which are pressured early decisions predicated on immediate acceptance. Other advantages of this system include its operation through a central application service to avoid redundancy of submitted paperwork, as well as to create greater awareness and to publicize training options and standardization of the match timeline.1
In its current state, the orthopedic sports medicine match represents 96 programs with 230 positions, accounting for approximately 97% of training programs and fellowship positions.1 While unaccredited options remain available through the Match, many programs have migrated towards American Council for Graduate Medical Education (ACGME) accreditation because of an increased focus on objective learning metrics during fellowship and the requirement for Subspecialty Certification in Orthopaedic Sports Medicine through the American Board of Orthopaedic Surgery.3 However, other programs have also eschewed the increasing constraints and administrative resources associated with ACGME accreditation, particularly among fellowships based at community-based hospitals or private practices that lack formal affiliation with academic institutions or residency training programs.
Along with a greater understanding of the historical background of the match process, fellowship applicants must also appreciate the relative merits of fellowship training. More than 90% of orthopedic surgery residents now pursue further subspecialty fellowship training, with some individuals opting for 2 additional fellowship opportunities.4 As a so-called “nontraditional applicant,” I represent a different demographic, returning to fellowship after years of clinical practice while serving in the military. Individual preferences notwithstanding, I wanted to take the opportunity to emphasize some important considerations in deliberating between different fellowship programs.
- Geography. Your eventual desired practice location may play a role in determining fellowship location or, at least, region of the country. Additionally, this can be an important factor in family happiness. In competitive markets, such as the Northeast or the West Coast, you may make inroads and establish professional connections that result in potential job opportunities. Conversely, other programs may adopt anticompetitive measures to limit local practice options.
- Training setting. Despite the trending consolidation of fellowship training programs in affiliated university and hospital-based teaching systems, many community-based programs and private-practice models thrive, providing an alternative to traditional academic training centers. The latter may provide more in-depth exposure to practice management, billing/coding, and ancillary services. The former typically offer a more structured, academically oriented environment with formal teaching conferences and a broader department hierarchy.
- Program size. Some applicants may prefer a larger, more diverse array of teaching staff or fellows, while others gravitate toward fewer, more personal mentoring relationships that allow more intimate familiarity with practice habits or surgical techniques.
- Associated training programs. Affiliations with a residency or physician-extender training program can offer benefits and drawbacks, including offloading clerical work, shared hands-on experience in the clinic and operating room, and midlevel supervisory responsibilities. This can offer useful opportunities to formulate an individual teaching style and valuable mentoring relationships. However, it can also impose greater time requirements or detract from one-on-one teaching with staff.
- Reputation. Applicants may attach distinction to a well-established regional or national reputation associated with a given training program. Often, certain programs may carry prestige as a result of their academic name, hospital affiliation, or accomplishments. This can offer certain marketing advantages for patient recruitment. However, less renowned programs may provide better training opportunities and confer higher esteem among your professional colleagues. Program reputation can change dramatically with time, so this should be balanced with other potential strengths and overall training experience.
- Practice “niches”/areas of interest. With increasing adoption of arthroscopic techniques among practicing surgeons and a relative excess of sports medicine–trained orthopedists, it is paramount to develop a novel skill set during fellowship to differentiate you from other graduates. I sought a sports medicine fellowship that would offer me a broad-based exposure to arthroscopic and open knee and shoulder reconstruction, chondral restoration techniques, hip arthroscopy and preservation, and shoulder arthroplasty. Opportunities in elbow reconstruction, foot and ankle arthroscopy, and pediatric sports medicine may also be valuable as a distinguishing factor in searching for jobs after training.
- Marketability. Closely intertwined with reputation and scope of practice, an institution’s marketability is another intangible attribute to consider. Professional or collegiate team coverage offers significant market value for patient advertising, and it is frequently publicized by orthopedic practices and hospital systems. Additionally, the importance of ACGME accreditation should also be considered.
- Nonmedical training. This is increasingly important in subsequent subspecialty training. Further education on the business aspects of orthopedic surgery should be emphasized. Additionally, dedicated curricula on professional or leadership development are important for career progression.
- Mentorship. Throughout the interview process, one of my foremost priorities was a strong and enduring pattern of mentorship. Fellowship offers the opportunity to establish 1 or multiple mentors in your subspecialty. These individuals will be instrumental in the development of your early professional career and your approach to clinical practice. From discussions about complicated patients to advice on contract negotiations, your ideal mentor should champion your early successes and work generously on your behalf, even long after fellowship has ended.
- Research opportunities. Given my academic career goals, I actively pursued a program with rich clinical and laboratory resources, and an established infrastructure for accomplishing high-quality, relevant research. Interested individuals should gauge the availability of research support staff, biomechanical or bench-level laboratory collaboration, grant or institutional research funding, cadaveric specimens, or clinical outcomes data for research conducted by fellows. However, not all fellowship applicants have a vested interest in research during fellowship, so I would encourage inquiries regarding core research requirements and expectations.
- Clinical exposure. This encompasses several different and equally important variables, including diversity of clinical or surgical caseloads, case complexity, operative exposure, athletic team coverage, and office or clinical experience. Interestingly, this latter aspect of training is often neglected but cannot be overemphasized. Outpatient clinical evaluation is key to honing important physical examination techniques and critically evaluating patients’ outcomes postoperatively.
- Surgical autonomy. Hands-on operative experience and surgical autonomy vary widely among fellowship programs. Most fellowships advocate for a graduated level of surgical responsibility dependent on individual abilities and staff comfort, while others offer greater potential for independence. Conversely, some programs espouse more of an “observership” model, and arthroscopic simulators and/or cadaveric skills laboratories are designed to complement operative experience. While most fellowship applicants desire maximal case participation, we must also recognize the value in watching talented surgeons performing technically demanding procedures.
- Family. You cannot put a premium on your personal contentment and family’s well-being. Proximity to a support network can be important with the work demands and time constraints of fellowship.
Despite financial obligations and significant time commitments, the fellowship match process offers an incredible range of programs and practice environments. Inevitably, no program can completely fulfill all your criteria, but you should be able to tailor your learning style, professional ambitions, and personal preferences with an excellent training program. For many, fellowship represents the last, and perhaps most integral, stage of formal surgical training. Considering all factors of your chosen fellowship program will ensure a rich and fulfilling educational experience.
The Orthopaedic Sports Medicine Fellowship Match was first established in 2008 as a joint-sponsored venture between the American Orthopaedic Society for Sports Medicine and the Arthroscopy Association of North America to pair applicants with participating training programs.1 Operated under the San Francisco Match,2 the current fellowship match process was adopted to systematically coordinate training appointments and eliminate the role of “exploding offers,” which are pressured early decisions predicated on immediate acceptance. Other advantages of this system include its operation through a central application service to avoid redundancy of submitted paperwork, as well as to create greater awareness and to publicize training options and standardization of the match timeline.1
In its current state, the orthopedic sports medicine match represents 96 programs with 230 positions, accounting for approximately 97% of training programs and fellowship positions.1 While unaccredited options remain available through the Match, many programs have migrated towards American Council for Graduate Medical Education (ACGME) accreditation because of an increased focus on objective learning metrics during fellowship and the requirement for Subspecialty Certification in Orthopaedic Sports Medicine through the American Board of Orthopaedic Surgery.3 However, other programs have also eschewed the increasing constraints and administrative resources associated with ACGME accreditation, particularly among fellowships based at community-based hospitals or private practices that lack formal affiliation with academic institutions or residency training programs.
Along with a greater understanding of the historical background of the match process, fellowship applicants must also appreciate the relative merits of fellowship training. More than 90% of orthopedic surgery residents now pursue further subspecialty fellowship training, with some individuals opting for 2 additional fellowship opportunities.4 As a so-called “nontraditional applicant,” I represent a different demographic, returning to fellowship after years of clinical practice while serving in the military. Individual preferences notwithstanding, I wanted to take the opportunity to emphasize some important considerations in deliberating between different fellowship programs.
- Geography. Your eventual desired practice location may play a role in determining fellowship location or, at least, region of the country. Additionally, this can be an important factor in family happiness. In competitive markets, such as the Northeast or the West Coast, you may make inroads and establish professional connections that result in potential job opportunities. Conversely, other programs may adopt anticompetitive measures to limit local practice options.
- Training setting. Despite the trending consolidation of fellowship training programs in affiliated university and hospital-based teaching systems, many community-based programs and private-practice models thrive, providing an alternative to traditional academic training centers. The latter may provide more in-depth exposure to practice management, billing/coding, and ancillary services. The former typically offer a more structured, academically oriented environment with formal teaching conferences and a broader department hierarchy.
- Program size. Some applicants may prefer a larger, more diverse array of teaching staff or fellows, while others gravitate toward fewer, more personal mentoring relationships that allow more intimate familiarity with practice habits or surgical techniques.
- Associated training programs. Affiliations with a residency or physician-extender training program can offer benefits and drawbacks, including offloading clerical work, shared hands-on experience in the clinic and operating room, and midlevel supervisory responsibilities. This can offer useful opportunities to formulate an individual teaching style and valuable mentoring relationships. However, it can also impose greater time requirements or detract from one-on-one teaching with staff.
- Reputation. Applicants may attach distinction to a well-established regional or national reputation associated with a given training program. Often, certain programs may carry prestige as a result of their academic name, hospital affiliation, or accomplishments. This can offer certain marketing advantages for patient recruitment. However, less renowned programs may provide better training opportunities and confer higher esteem among your professional colleagues. Program reputation can change dramatically with time, so this should be balanced with other potential strengths and overall training experience.
- Practice “niches”/areas of interest. With increasing adoption of arthroscopic techniques among practicing surgeons and a relative excess of sports medicine–trained orthopedists, it is paramount to develop a novel skill set during fellowship to differentiate you from other graduates. I sought a sports medicine fellowship that would offer me a broad-based exposure to arthroscopic and open knee and shoulder reconstruction, chondral restoration techniques, hip arthroscopy and preservation, and shoulder arthroplasty. Opportunities in elbow reconstruction, foot and ankle arthroscopy, and pediatric sports medicine may also be valuable as a distinguishing factor in searching for jobs after training.
- Marketability. Closely intertwined with reputation and scope of practice, an institution’s marketability is another intangible attribute to consider. Professional or collegiate team coverage offers significant market value for patient advertising, and it is frequently publicized by orthopedic practices and hospital systems. Additionally, the importance of ACGME accreditation should also be considered.
- Nonmedical training. This is increasingly important in subsequent subspecialty training. Further education on the business aspects of orthopedic surgery should be emphasized. Additionally, dedicated curricula on professional or leadership development are important for career progression.
- Mentorship. Throughout the interview process, one of my foremost priorities was a strong and enduring pattern of mentorship. Fellowship offers the opportunity to establish 1 or multiple mentors in your subspecialty. These individuals will be instrumental in the development of your early professional career and your approach to clinical practice. From discussions about complicated patients to advice on contract negotiations, your ideal mentor should champion your early successes and work generously on your behalf, even long after fellowship has ended.
- Research opportunities. Given my academic career goals, I actively pursued a program with rich clinical and laboratory resources, and an established infrastructure for accomplishing high-quality, relevant research. Interested individuals should gauge the availability of research support staff, biomechanical or bench-level laboratory collaboration, grant or institutional research funding, cadaveric specimens, or clinical outcomes data for research conducted by fellows. However, not all fellowship applicants have a vested interest in research during fellowship, so I would encourage inquiries regarding core research requirements and expectations.
- Clinical exposure. This encompasses several different and equally important variables, including diversity of clinical or surgical caseloads, case complexity, operative exposure, athletic team coverage, and office or clinical experience. Interestingly, this latter aspect of training is often neglected but cannot be overemphasized. Outpatient clinical evaluation is key to honing important physical examination techniques and critically evaluating patients’ outcomes postoperatively.
- Surgical autonomy. Hands-on operative experience and surgical autonomy vary widely among fellowship programs. Most fellowships advocate for a graduated level of surgical responsibility dependent on individual abilities and staff comfort, while others offer greater potential for independence. Conversely, some programs espouse more of an “observership” model, and arthroscopic simulators and/or cadaveric skills laboratories are designed to complement operative experience. While most fellowship applicants desire maximal case participation, we must also recognize the value in watching talented surgeons performing technically demanding procedures.
- Family. You cannot put a premium on your personal contentment and family’s well-being. Proximity to a support network can be important with the work demands and time constraints of fellowship.
Despite financial obligations and significant time commitments, the fellowship match process offers an incredible range of programs and practice environments. Inevitably, no program can completely fulfill all your criteria, but you should be able to tailor your learning style, professional ambitions, and personal preferences with an excellent training program. For many, fellowship represents the last, and perhaps most integral, stage of formal surgical training. Considering all factors of your chosen fellowship program will ensure a rich and fulfilling educational experience.
1. Sports medicine/arthroscopy fellowship match. American Orthopaedic Society for Sports Medicine website. https://www.sportsmed.org/AOSSMIMIS/Members/Members/Education/Sports_Medicine_Arthroscopy_Fellowship_Match.aspx. Accessed December 21, 2015.
2. Orthopaedic sports medicine fellowship. SF Match website. https://www.sfmatch.org/SpecialtyInsideAll.aspx?id=11&typ=1&name=Orthopaedic%20Sports%20Medicine. Accessed December 21, 2015.
3. Orthopaedic sports medicine. American Board of Orthopaedic Surgery website. https://www.abos.org/certification/sports-subspecialty.aspx. Accessed December 21, 2015.
4. Hariri S, York SC, O’Connor MI, Parsley BS, McCarthy JC. Career plans of current orthopaedic residents with a focus on sex-based and generational differences. J Bone Joint Surg Am. 2011;93(5):e16.
1. Sports medicine/arthroscopy fellowship match. American Orthopaedic Society for Sports Medicine website. https://www.sportsmed.org/AOSSMIMIS/Members/Members/Education/Sports_Medicine_Arthroscopy_Fellowship_Match.aspx. Accessed December 21, 2015.
2. Orthopaedic sports medicine fellowship. SF Match website. https://www.sfmatch.org/SpecialtyInsideAll.aspx?id=11&typ=1&name=Orthopaedic%20Sports%20Medicine. Accessed December 21, 2015.
3. Orthopaedic sports medicine. American Board of Orthopaedic Surgery website. https://www.abos.org/certification/sports-subspecialty.aspx. Accessed December 21, 2015.
4. Hariri S, York SC, O’Connor MI, Parsley BS, McCarthy JC. Career plans of current orthopaedic residents with a focus on sex-based and generational differences. J Bone Joint Surg Am. 2011;93(5):e16.
Forgoing artificial nutrition and hydration
Question: Which of the following statements regarding artificial nutrition and hydration (ANH) is least supported in ethics and/or law?
A. One may invoke medical futility and discontinue ANH in noncognitive, terminally ill patients.
B. Forgoing ANH at the end of life is part of good palliative care.
C. Tube feeding is a way to provide food and sustenance and does not constitute medical treatment.
D. Many state statutes allow for the discontinuation of ANH under specified conditions.
E. Discontinuing ANH is most contentious when it affects a young, otherwise healthy person in a persistent vegetative state.
Answer: C.
Only a few decades ago, litigation over end-of-life care took the form of surrogates demanding to stop treatment, e.g., mechanical ventilation, against the orders of the hospital and doctors.1 The parties now tend to reverse their positions, with some families insisting on continuing all treatment modalities, especially artificial nutrition and hydration (ANH) such as tube feedings. Medical futility has been variously defined as an intervention that has no pathophysiologic rationale, where such intervention had already failed in the patient, where maximal treatment is already failing, or where the intervention will not achieve the goals of care. The AMA Code of Medical Ethics advises: “Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them.”2 The AMA Code also clarifies that “life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition” and “may include … artificial nutrition and hydration.”3
Although many palliative care specialists have deemed ANH to be of dubious medical benefit at the end of life,4 forgoing ANH nonetheless poses a particularly contentious dilemma. Opponents assert that ANH is a form of feeding rather than medical treatment, denial of which amounts to “starving” the patient to death. However in 1990, the U.S. Supreme Court in Cruzan v. Director5 declared that ANH could not be readily distinguished from other forms of medical treatment. The case involved a 25-year-old woman who lapsed into a persistent vegetative state (PVS) following an automobile accident. Her parents sought a court order to withdraw ANH when it became apparent that she had virtually no chance of recovering her cognitive faculties. Writing for a unanimous Supreme Court, Justice O’Connor opined: “Whether or not the techniques used to pass food and water into the patient’s alimentary tract are termed ‘medical treatment,’ it is clear they all involve some degree of intrusion and restraint. … Feeding a patient by means of a nasogastric tube requires a physician to pass a long flexible tube through the patient’s nose, throat, and esophagus and into the stomach. Because of the discomfort such a tube causes, ‘many patients need to be restrained forcibly and their hands put into large mittens to prevent them from removing the tube.’ A gastrostomy tube … or jejunostomy tube must be surgically implanted into the stomach or small intestine. … Requiring a competent adult to endure such procedures against her will burdens the patient’s liberty, dignity, and freedom to determine the course of her own treatment.”
The English High Court has likewise adopted this position in Airedale NHS Trust v. Bland.6 Tony Bland, a young man, was crushed in a Hillsborough football melee in 1989, which caused him to develop PVS. The court wrote: “The question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of medical treatment or care. The correct formulation of the question is of particular importance in a case such as the present, where the patient is totally unconscious or where there is no hope whatsoever of any amelioration of his condition.”
In 2005, the United States witnessed its most public and highly politicized case regarding the withdrawal of ANH.7 In 1990, Terri Schiavo, then age 26, sustained a cardiac arrest, possibly caused by an eating disorder and hypokalemia. Her husband, Michael, filed a malpractice suit and won damages of $1.5 million, but the arrest left her in a PVS. Terri had left no advance directive, and her husband said she would rather die than be kept alive artificially, and therefore directed that her tube feeding be stopped. On the other hand, her parents Bob and Mary Schindler wished to keep her alive, and volunteered to take care of her. After a long and bitter legal battle, an appellate court finally agreed to stop Terri’s tube feeding, as it found clear and convincing evidence that she would not have wanted to live in that manner. The U.S. Supreme Court refused to review the case. On Oct. 15, 2003, with the discontinuation of her tube feeding, Terri’s parents appealed to then Florida Gov. Jeb Bush, calling into question the diagnosis of PVS. They insisted Terri’s eyes were open, and she appeared to respond with smiles to the sound of her mother’s voice. Despite contrary expert opinion, 15 doctors testified she could and would improve. Both the Florida legislature and the U.S. Congress intervened but to no avail. Terri died at 10 a.m. on March 31, 2005, 13 days after tube withdrawal. An autopsy revealed severe brain atrophy.
In Cruzan, the U.S. Supreme Court had held that the liberty guaranteed by the Due Process Clause must protect an individual’s deeply personal decision to reject medical treatment, including the artificial delivery of food and water. However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment. In a 6-0 decision, the California Supreme Court ruled that a patient’s tube feedings could not be discontinued under the circumstances of the Wendland case.8 Robert Wendland regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, the county ombudsman, and a court-appointed counsel all agreed with the decision. Robert did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state. But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.
In some jurisdictions, a patient’s advance medical directive to discontinue ANH may require a specific opt-in or opt-out choice. And although medical directives typically spring into effect when a patient is terminally ill, many jurisdictions allow their applicability in nonterminal conditions such as irreversible unconscious states or where the likely risks and burdens of treatment would outweigh any expected benefits (Hawaii is such a state under HRS §327E-16). Physicians are legally bound to respect a patient’s wish regarding forgoing or continuing therapy including ANH. Given the wide variations in legal requirements governing this emotional matter, physicians must look closely at their individual state statute to determine the proper course of action under the circumstances.
References
1. In re Quinlan, 70 N.J. 10 (1976).
2. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.035.
3. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.20.
4. Danis M. Stopping artificial nutrition and hydration at the end of life. UpToDate, Nov 2, 2015.
5. Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990).
6. Airedale NHS Trust v. Bland (1993) A.C. 789.
7. Available at https://en.wikipedia.org/wiki/Terri_Schiavo_case.
8. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Question: Which of the following statements regarding artificial nutrition and hydration (ANH) is least supported in ethics and/or law?
A. One may invoke medical futility and discontinue ANH in noncognitive, terminally ill patients.
B. Forgoing ANH at the end of life is part of good palliative care.
C. Tube feeding is a way to provide food and sustenance and does not constitute medical treatment.
D. Many state statutes allow for the discontinuation of ANH under specified conditions.
E. Discontinuing ANH is most contentious when it affects a young, otherwise healthy person in a persistent vegetative state.
Answer: C.
Only a few decades ago, litigation over end-of-life care took the form of surrogates demanding to stop treatment, e.g., mechanical ventilation, against the orders of the hospital and doctors.1 The parties now tend to reverse their positions, with some families insisting on continuing all treatment modalities, especially artificial nutrition and hydration (ANH) such as tube feedings. Medical futility has been variously defined as an intervention that has no pathophysiologic rationale, where such intervention had already failed in the patient, where maximal treatment is already failing, or where the intervention will not achieve the goals of care. The AMA Code of Medical Ethics advises: “Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them.”2 The AMA Code also clarifies that “life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition” and “may include … artificial nutrition and hydration.”3
Although many palliative care specialists have deemed ANH to be of dubious medical benefit at the end of life,4 forgoing ANH nonetheless poses a particularly contentious dilemma. Opponents assert that ANH is a form of feeding rather than medical treatment, denial of which amounts to “starving” the patient to death. However in 1990, the U.S. Supreme Court in Cruzan v. Director5 declared that ANH could not be readily distinguished from other forms of medical treatment. The case involved a 25-year-old woman who lapsed into a persistent vegetative state (PVS) following an automobile accident. Her parents sought a court order to withdraw ANH when it became apparent that she had virtually no chance of recovering her cognitive faculties. Writing for a unanimous Supreme Court, Justice O’Connor opined: “Whether or not the techniques used to pass food and water into the patient’s alimentary tract are termed ‘medical treatment,’ it is clear they all involve some degree of intrusion and restraint. … Feeding a patient by means of a nasogastric tube requires a physician to pass a long flexible tube through the patient’s nose, throat, and esophagus and into the stomach. Because of the discomfort such a tube causes, ‘many patients need to be restrained forcibly and their hands put into large mittens to prevent them from removing the tube.’ A gastrostomy tube … or jejunostomy tube must be surgically implanted into the stomach or small intestine. … Requiring a competent adult to endure such procedures against her will burdens the patient’s liberty, dignity, and freedom to determine the course of her own treatment.”
The English High Court has likewise adopted this position in Airedale NHS Trust v. Bland.6 Tony Bland, a young man, was crushed in a Hillsborough football melee in 1989, which caused him to develop PVS. The court wrote: “The question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of medical treatment or care. The correct formulation of the question is of particular importance in a case such as the present, where the patient is totally unconscious or where there is no hope whatsoever of any amelioration of his condition.”
In 2005, the United States witnessed its most public and highly politicized case regarding the withdrawal of ANH.7 In 1990, Terri Schiavo, then age 26, sustained a cardiac arrest, possibly caused by an eating disorder and hypokalemia. Her husband, Michael, filed a malpractice suit and won damages of $1.5 million, but the arrest left her in a PVS. Terri had left no advance directive, and her husband said she would rather die than be kept alive artificially, and therefore directed that her tube feeding be stopped. On the other hand, her parents Bob and Mary Schindler wished to keep her alive, and volunteered to take care of her. After a long and bitter legal battle, an appellate court finally agreed to stop Terri’s tube feeding, as it found clear and convincing evidence that she would not have wanted to live in that manner. The U.S. Supreme Court refused to review the case. On Oct. 15, 2003, with the discontinuation of her tube feeding, Terri’s parents appealed to then Florida Gov. Jeb Bush, calling into question the diagnosis of PVS. They insisted Terri’s eyes were open, and she appeared to respond with smiles to the sound of her mother’s voice. Despite contrary expert opinion, 15 doctors testified she could and would improve. Both the Florida legislature and the U.S. Congress intervened but to no avail. Terri died at 10 a.m. on March 31, 2005, 13 days after tube withdrawal. An autopsy revealed severe brain atrophy.
In Cruzan, the U.S. Supreme Court had held that the liberty guaranteed by the Due Process Clause must protect an individual’s deeply personal decision to reject medical treatment, including the artificial delivery of food and water. However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment. In a 6-0 decision, the California Supreme Court ruled that a patient’s tube feedings could not be discontinued under the circumstances of the Wendland case.8 Robert Wendland regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, the county ombudsman, and a court-appointed counsel all agreed with the decision. Robert did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state. But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.
In some jurisdictions, a patient’s advance medical directive to discontinue ANH may require a specific opt-in or opt-out choice. And although medical directives typically spring into effect when a patient is terminally ill, many jurisdictions allow their applicability in nonterminal conditions such as irreversible unconscious states or where the likely risks and burdens of treatment would outweigh any expected benefits (Hawaii is such a state under HRS §327E-16). Physicians are legally bound to respect a patient’s wish regarding forgoing or continuing therapy including ANH. Given the wide variations in legal requirements governing this emotional matter, physicians must look closely at their individual state statute to determine the proper course of action under the circumstances.
References
1. In re Quinlan, 70 N.J. 10 (1976).
2. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.035.
3. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.20.
4. Danis M. Stopping artificial nutrition and hydration at the end of life. UpToDate, Nov 2, 2015.
5. Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990).
6. Airedale NHS Trust v. Bland (1993) A.C. 789.
7. Available at https://en.wikipedia.org/wiki/Terri_Schiavo_case.
8. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Question: Which of the following statements regarding artificial nutrition and hydration (ANH) is least supported in ethics and/or law?
A. One may invoke medical futility and discontinue ANH in noncognitive, terminally ill patients.
B. Forgoing ANH at the end of life is part of good palliative care.
C. Tube feeding is a way to provide food and sustenance and does not constitute medical treatment.
D. Many state statutes allow for the discontinuation of ANH under specified conditions.
E. Discontinuing ANH is most contentious when it affects a young, otherwise healthy person in a persistent vegetative state.
Answer: C.
Only a few decades ago, litigation over end-of-life care took the form of surrogates demanding to stop treatment, e.g., mechanical ventilation, against the orders of the hospital and doctors.1 The parties now tend to reverse their positions, with some families insisting on continuing all treatment modalities, especially artificial nutrition and hydration (ANH) such as tube feedings. Medical futility has been variously defined as an intervention that has no pathophysiologic rationale, where such intervention had already failed in the patient, where maximal treatment is already failing, or where the intervention will not achieve the goals of care. The AMA Code of Medical Ethics advises: “Physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. Patients should not be given treatments simply because they demand them.”2 The AMA Code also clarifies that “life-sustaining treatment is any treatment that serves to prolong life without reversing the underlying medical condition” and “may include … artificial nutrition and hydration.”3
Although many palliative care specialists have deemed ANH to be of dubious medical benefit at the end of life,4 forgoing ANH nonetheless poses a particularly contentious dilemma. Opponents assert that ANH is a form of feeding rather than medical treatment, denial of which amounts to “starving” the patient to death. However in 1990, the U.S. Supreme Court in Cruzan v. Director5 declared that ANH could not be readily distinguished from other forms of medical treatment. The case involved a 25-year-old woman who lapsed into a persistent vegetative state (PVS) following an automobile accident. Her parents sought a court order to withdraw ANH when it became apparent that she had virtually no chance of recovering her cognitive faculties. Writing for a unanimous Supreme Court, Justice O’Connor opined: “Whether or not the techniques used to pass food and water into the patient’s alimentary tract are termed ‘medical treatment,’ it is clear they all involve some degree of intrusion and restraint. … Feeding a patient by means of a nasogastric tube requires a physician to pass a long flexible tube through the patient’s nose, throat, and esophagus and into the stomach. Because of the discomfort such a tube causes, ‘many patients need to be restrained forcibly and their hands put into large mittens to prevent them from removing the tube.’ A gastrostomy tube … or jejunostomy tube must be surgically implanted into the stomach or small intestine. … Requiring a competent adult to endure such procedures against her will burdens the patient’s liberty, dignity, and freedom to determine the course of her own treatment.”
The English High Court has likewise adopted this position in Airedale NHS Trust v. Bland.6 Tony Bland, a young man, was crushed in a Hillsborough football melee in 1989, which caused him to develop PVS. The court wrote: “The question is not whether it is in the best interests of the patient that he should die. The question is whether it is in the best interests of the patient that his life should be prolonged by the continuance of this form of medical treatment or care. The correct formulation of the question is of particular importance in a case such as the present, where the patient is totally unconscious or where there is no hope whatsoever of any amelioration of his condition.”
In 2005, the United States witnessed its most public and highly politicized case regarding the withdrawal of ANH.7 In 1990, Terri Schiavo, then age 26, sustained a cardiac arrest, possibly caused by an eating disorder and hypokalemia. Her husband, Michael, filed a malpractice suit and won damages of $1.5 million, but the arrest left her in a PVS. Terri had left no advance directive, and her husband said she would rather die than be kept alive artificially, and therefore directed that her tube feeding be stopped. On the other hand, her parents Bob and Mary Schindler wished to keep her alive, and volunteered to take care of her. After a long and bitter legal battle, an appellate court finally agreed to stop Terri’s tube feeding, as it found clear and convincing evidence that she would not have wanted to live in that manner. The U.S. Supreme Court refused to review the case. On Oct. 15, 2003, with the discontinuation of her tube feeding, Terri’s parents appealed to then Florida Gov. Jeb Bush, calling into question the diagnosis of PVS. They insisted Terri’s eyes were open, and she appeared to respond with smiles to the sound of her mother’s voice. Despite contrary expert opinion, 15 doctors testified she could and would improve. Both the Florida legislature and the U.S. Congress intervened but to no avail. Terri died at 10 a.m. on March 31, 2005, 13 days after tube withdrawal. An autopsy revealed severe brain atrophy.
In Cruzan, the U.S. Supreme Court had held that the liberty guaranteed by the Due Process Clause must protect an individual’s deeply personal decision to reject medical treatment, including the artificial delivery of food and water. However, where a patient’s wishes are not clear and convincing, a court will be reluctant to order cessation of treatment. In a 6-0 decision, the California Supreme Court ruled that a patient’s tube feedings could not be discontinued under the circumstances of the Wendland case.8 Robert Wendland regained consciousness after 14 months in a coma, but was left hemiparetic and incontinent, and could not feed by mouth or dress, bathe, and communicate consistently. His wife, Rose, refused to authorize reinsertion of his dislodged feeding tube, believing that Robert would not have wanted it replaced. The patient’s daughter and brother, as well as the hospital’s ethics committee, the county ombudsman, and a court-appointed counsel all agreed with the decision. Robert did not have an advance directive, but had made statements to the effect he would not want to live in a vegetative state. But the patient’s mother, Florence, went to court to block the action. The court determined that Robert’s statements were not clear and convincing because they did not address his current condition, were not sufficiently specific, and were not necessarily intended to direct his medical care. Further, the patient’s spouse had failed to provide sufficient evidence that her decision was in her husband’s best interests.
In some jurisdictions, a patient’s advance medical directive to discontinue ANH may require a specific opt-in or opt-out choice. And although medical directives typically spring into effect when a patient is terminally ill, many jurisdictions allow their applicability in nonterminal conditions such as irreversible unconscious states or where the likely risks and burdens of treatment would outweigh any expected benefits (Hawaii is such a state under HRS §327E-16). Physicians are legally bound to respect a patient’s wish regarding forgoing or continuing therapy including ANH. Given the wide variations in legal requirements governing this emotional matter, physicians must look closely at their individual state statute to determine the proper course of action under the circumstances.
References
1. In re Quinlan, 70 N.J. 10 (1976).
2. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.035.
3. Code of Medical Ethics of the AMA, 2014-5 ed., section 2.20.
4. Danis M. Stopping artificial nutrition and hydration at the end of life. UpToDate, Nov 2, 2015.
5. Cruzan v. Director, Missouri Department of Health, 110 S. Ct. 2841 (1990).
6. Airedale NHS Trust v. Bland (1993) A.C. 789.
7. Available at https://en.wikipedia.org/wiki/Terri_Schiavo_case.
8. Wendland v. Wendland, 28 P.3d 151 (Cal., 2001).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].
Seeking an alteplase alternative for stroke
Where is a biosimilar when you need one?
A few weeks ago, I reported on an advisory committee of the Food and Drug Administration overwhelmingly recommending that the agency approve a biosimilar form of infliximab. If the FDA follows this recommendation, and every indication was that it would, it would become the second biosimilar drug approved for U.S. marketing, and a top agency official recently noted during Congressional testimony that the FDA biosimilar program had 59 additional agents working their way through the agency’s development program. A 2014 report cited more than 700 biosimilars under development worldwide.
But when analysts and journalists list the top reference drugs for biosimilars in the pipeline, one reference biologic agent conspicuously absent is alteplase, the thrombolytic also known as tissue plasminogen activator (TPA), which is approved for lysing clots that cause MIs and acute ischemic strokes.
Alteplase, marketed under the brand name Activase, is the only thrombolytic drug with U.S. approval for treating acute ischemic stroke. Although results from several studies published in 2015 rapidly boosted endovascular thrombectomy to physically remove clots causing acute ischemic strokes, this new intervention has by no means relegated intravenous alteplase to the sidelines. Experts I spoke with in February at the International Stroke Conference unanimously endorsed treatment with alteplase as the unshaken keystone of acute ischemic stroke treatment (for appropriate patients), even in the thrombectomy era. Thrombolysis is seen as a complement to thrombectomy rather than a treatment eclipsed by thrombectomy.
Although alteplase treatment remains central it’s also become increasingly expensive. According to a report at the Stroke Conference by Dr. Dawn Kleindorfer, a neurologist and co–medical director of the comprehensive stroke center at the University of Cincinnati, the price paid by Medicare for alteplase given to acute ischemic stroke patients more than doubled during 2005-2014. Upward pricing became especially dramatic starting in 2010, she noted, with a price tag of about $6,400/100 mg vial (enough for roughly one dose) by mid-2014. The cost for alteplase jumped from 27% of the amount hospitals got reimbursed by Medicare for treating a patient with acute ischemic stroke in 2006 to 53% of the reimbursement in 2013, Dr. Kleindorfer reported.
“I think this might impact the ability of hospitals to provide health care because the [alteplase] cost is so high and now more than half the reimbursement,” she warned. Despite its high price, alteplase “remains cost effective,” she noted, and use of the drug in recent years has increased, not dropped.
Dr. Kleindorfer was at a complete loss to explain why alteplase’s price has risen so much since 2010, and she noted that the drug received FDA approval in 1996 and is now off patent for the acute ischemic stroke indication (as well as the acute MI indication). Despite that, no biosimilar has appeared or seems to be under announced development, nor has any other thrombolytic drug received FDA approval for the stroke indication.
In fact, the history of thrombolytics for acute ischemic stroke is notably checkered. For example, an alternative thrombolytic, desmoteplase, showed early signs of promise for treating acute ischemic stroke, but the Danish drug company Lundbeck halted development of desmoteplase in late 2014 after the drug failed to achieve target primary endpoints in pivotal trials. Another thrombolytic, reteplase (Retavase), has had FDA approval for treating acute MI since 1996 but has never received approval for acute ischemic stroke. A spokesperson for Chiesi, the company that currently markets Retavase, declined to comment on why an indication for stroke was never pursued. A third thrombolytic similar to alteplase, tenecteplase, showed promise for treating acute ischemic stroke in a relatively recent phase II study, where it actually showed superiority to alteplase in a head-to-head comparison, but tenecteplase is owned and marketed by Genentech as TNKase (for acute MI only), the same company that also markets alteplase and so has little incentive to develop tenecteplase as an alternative stroke treatment.
“Even a doubling of the price [for TPA, alteplase] doesn’t change whether the drug is cost effective, but this effectively reduces hospital reimbursements that support acute stroke programs,” commented Dr. S. Claiborne Johnston in an interview. “This will ultimately impact the enthusiasm for and use of TPA,” predicted Dr. Johnston, dean of the Dell Medical School of the University of Texas in Austin and a researcher who has analyzed the economics of thrombolytic drugs for acute ischemic stroke.
“The lack of competition [to alteplase for treating acute ischemic stroke] is an example of how our current biopharma marketplace is dysfunctional,” Dr. Johnston told me. “Trials of new agents are difficult, expensive, and protracted, and there is some question whether any agent that works better [than alteplase] at lysing a clot would also produce a higher hemorrhage risk. We really need a biosimilar, but the path to develop this is not as easy as for [generic] drugs.” Although the higher price alteplase now commands might make development of a biosimilar even more attractive, Dr. Johnston said he was unaware of any company that so far is venturing down that path.
On Twitter @mitchelzoler
Where is a biosimilar when you need one?
A few weeks ago, I reported on an advisory committee of the Food and Drug Administration overwhelmingly recommending that the agency approve a biosimilar form of infliximab. If the FDA follows this recommendation, and every indication was that it would, it would become the second biosimilar drug approved for U.S. marketing, and a top agency official recently noted during Congressional testimony that the FDA biosimilar program had 59 additional agents working their way through the agency’s development program. A 2014 report cited more than 700 biosimilars under development worldwide.
But when analysts and journalists list the top reference drugs for biosimilars in the pipeline, one reference biologic agent conspicuously absent is alteplase, the thrombolytic also known as tissue plasminogen activator (TPA), which is approved for lysing clots that cause MIs and acute ischemic strokes.
Alteplase, marketed under the brand name Activase, is the only thrombolytic drug with U.S. approval for treating acute ischemic stroke. Although results from several studies published in 2015 rapidly boosted endovascular thrombectomy to physically remove clots causing acute ischemic strokes, this new intervention has by no means relegated intravenous alteplase to the sidelines. Experts I spoke with in February at the International Stroke Conference unanimously endorsed treatment with alteplase as the unshaken keystone of acute ischemic stroke treatment (for appropriate patients), even in the thrombectomy era. Thrombolysis is seen as a complement to thrombectomy rather than a treatment eclipsed by thrombectomy.
Although alteplase treatment remains central it’s also become increasingly expensive. According to a report at the Stroke Conference by Dr. Dawn Kleindorfer, a neurologist and co–medical director of the comprehensive stroke center at the University of Cincinnati, the price paid by Medicare for alteplase given to acute ischemic stroke patients more than doubled during 2005-2014. Upward pricing became especially dramatic starting in 2010, she noted, with a price tag of about $6,400/100 mg vial (enough for roughly one dose) by mid-2014. The cost for alteplase jumped from 27% of the amount hospitals got reimbursed by Medicare for treating a patient with acute ischemic stroke in 2006 to 53% of the reimbursement in 2013, Dr. Kleindorfer reported.
“I think this might impact the ability of hospitals to provide health care because the [alteplase] cost is so high and now more than half the reimbursement,” she warned. Despite its high price, alteplase “remains cost effective,” she noted, and use of the drug in recent years has increased, not dropped.
Dr. Kleindorfer was at a complete loss to explain why alteplase’s price has risen so much since 2010, and she noted that the drug received FDA approval in 1996 and is now off patent for the acute ischemic stroke indication (as well as the acute MI indication). Despite that, no biosimilar has appeared or seems to be under announced development, nor has any other thrombolytic drug received FDA approval for the stroke indication.
In fact, the history of thrombolytics for acute ischemic stroke is notably checkered. For example, an alternative thrombolytic, desmoteplase, showed early signs of promise for treating acute ischemic stroke, but the Danish drug company Lundbeck halted development of desmoteplase in late 2014 after the drug failed to achieve target primary endpoints in pivotal trials. Another thrombolytic, reteplase (Retavase), has had FDA approval for treating acute MI since 1996 but has never received approval for acute ischemic stroke. A spokesperson for Chiesi, the company that currently markets Retavase, declined to comment on why an indication for stroke was never pursued. A third thrombolytic similar to alteplase, tenecteplase, showed promise for treating acute ischemic stroke in a relatively recent phase II study, where it actually showed superiority to alteplase in a head-to-head comparison, but tenecteplase is owned and marketed by Genentech as TNKase (for acute MI only), the same company that also markets alteplase and so has little incentive to develop tenecteplase as an alternative stroke treatment.
“Even a doubling of the price [for TPA, alteplase] doesn’t change whether the drug is cost effective, but this effectively reduces hospital reimbursements that support acute stroke programs,” commented Dr. S. Claiborne Johnston in an interview. “This will ultimately impact the enthusiasm for and use of TPA,” predicted Dr. Johnston, dean of the Dell Medical School of the University of Texas in Austin and a researcher who has analyzed the economics of thrombolytic drugs for acute ischemic stroke.
“The lack of competition [to alteplase for treating acute ischemic stroke] is an example of how our current biopharma marketplace is dysfunctional,” Dr. Johnston told me. “Trials of new agents are difficult, expensive, and protracted, and there is some question whether any agent that works better [than alteplase] at lysing a clot would also produce a higher hemorrhage risk. We really need a biosimilar, but the path to develop this is not as easy as for [generic] drugs.” Although the higher price alteplase now commands might make development of a biosimilar even more attractive, Dr. Johnston said he was unaware of any company that so far is venturing down that path.
On Twitter @mitchelzoler
Where is a biosimilar when you need one?
A few weeks ago, I reported on an advisory committee of the Food and Drug Administration overwhelmingly recommending that the agency approve a biosimilar form of infliximab. If the FDA follows this recommendation, and every indication was that it would, it would become the second biosimilar drug approved for U.S. marketing, and a top agency official recently noted during Congressional testimony that the FDA biosimilar program had 59 additional agents working their way through the agency’s development program. A 2014 report cited more than 700 biosimilars under development worldwide.
But when analysts and journalists list the top reference drugs for biosimilars in the pipeline, one reference biologic agent conspicuously absent is alteplase, the thrombolytic also known as tissue plasminogen activator (TPA), which is approved for lysing clots that cause MIs and acute ischemic strokes.
Alteplase, marketed under the brand name Activase, is the only thrombolytic drug with U.S. approval for treating acute ischemic stroke. Although results from several studies published in 2015 rapidly boosted endovascular thrombectomy to physically remove clots causing acute ischemic strokes, this new intervention has by no means relegated intravenous alteplase to the sidelines. Experts I spoke with in February at the International Stroke Conference unanimously endorsed treatment with alteplase as the unshaken keystone of acute ischemic stroke treatment (for appropriate patients), even in the thrombectomy era. Thrombolysis is seen as a complement to thrombectomy rather than a treatment eclipsed by thrombectomy.
Although alteplase treatment remains central it’s also become increasingly expensive. According to a report at the Stroke Conference by Dr. Dawn Kleindorfer, a neurologist and co–medical director of the comprehensive stroke center at the University of Cincinnati, the price paid by Medicare for alteplase given to acute ischemic stroke patients more than doubled during 2005-2014. Upward pricing became especially dramatic starting in 2010, she noted, with a price tag of about $6,400/100 mg vial (enough for roughly one dose) by mid-2014. The cost for alteplase jumped from 27% of the amount hospitals got reimbursed by Medicare for treating a patient with acute ischemic stroke in 2006 to 53% of the reimbursement in 2013, Dr. Kleindorfer reported.
“I think this might impact the ability of hospitals to provide health care because the [alteplase] cost is so high and now more than half the reimbursement,” she warned. Despite its high price, alteplase “remains cost effective,” she noted, and use of the drug in recent years has increased, not dropped.
Dr. Kleindorfer was at a complete loss to explain why alteplase’s price has risen so much since 2010, and she noted that the drug received FDA approval in 1996 and is now off patent for the acute ischemic stroke indication (as well as the acute MI indication). Despite that, no biosimilar has appeared or seems to be under announced development, nor has any other thrombolytic drug received FDA approval for the stroke indication.
In fact, the history of thrombolytics for acute ischemic stroke is notably checkered. For example, an alternative thrombolytic, desmoteplase, showed early signs of promise for treating acute ischemic stroke, but the Danish drug company Lundbeck halted development of desmoteplase in late 2014 after the drug failed to achieve target primary endpoints in pivotal trials. Another thrombolytic, reteplase (Retavase), has had FDA approval for treating acute MI since 1996 but has never received approval for acute ischemic stroke. A spokesperson for Chiesi, the company that currently markets Retavase, declined to comment on why an indication for stroke was never pursued. A third thrombolytic similar to alteplase, tenecteplase, showed promise for treating acute ischemic stroke in a relatively recent phase II study, where it actually showed superiority to alteplase in a head-to-head comparison, but tenecteplase is owned and marketed by Genentech as TNKase (for acute MI only), the same company that also markets alteplase and so has little incentive to develop tenecteplase as an alternative stroke treatment.
“Even a doubling of the price [for TPA, alteplase] doesn’t change whether the drug is cost effective, but this effectively reduces hospital reimbursements that support acute stroke programs,” commented Dr. S. Claiborne Johnston in an interview. “This will ultimately impact the enthusiasm for and use of TPA,” predicted Dr. Johnston, dean of the Dell Medical School of the University of Texas in Austin and a researcher who has analyzed the economics of thrombolytic drugs for acute ischemic stroke.
“The lack of competition [to alteplase for treating acute ischemic stroke] is an example of how our current biopharma marketplace is dysfunctional,” Dr. Johnston told me. “Trials of new agents are difficult, expensive, and protracted, and there is some question whether any agent that works better [than alteplase] at lysing a clot would also produce a higher hemorrhage risk. We really need a biosimilar, but the path to develop this is not as easy as for [generic] drugs.” Although the higher price alteplase now commands might make development of a biosimilar even more attractive, Dr. Johnston said he was unaware of any company that so far is venturing down that path.
On Twitter @mitchelzoler
Zika virus gets rational response from physicians and patients
A few weeks ago, Ob.Gyn. News contributor Dr. Eskild Petersen advocated for a calm, reasoned approach to the Zika virus despite a climate of fear amid headlines about higher microcephaly rates among infected women in South America and sexual transmission routes.
New data show that U.S. gynecologists and obstetrician-gynecologists, and perhaps more importantly, their pregnant, or seeking to become pregnant, patients are doing just that. They are clearly aware of and monitoring the Zika virus, but not overreacting to it.
In a microsurvey conducted by InCrowd, a provider of real-time market intelligence to life sciences and health care firms, gynecologists and ob.gyns. were sticking to rather low-tech and commonsense practices, rather than extraordinary measures, to avoid the Zika virus.
Although 90% of gynecologists and ob.gyns. surveyed were recommending against travel to affected countries while their patients are expecting or looking to become pregnant, the doctors’ primary recommendations were use of mosquito protection and reading of online bulletins from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists prior to travel. Only a third of these doctors would automatically test for the Zika virus if the patient had been to an affected area. Physicians anticipate they could actively manage as many as 10 cases of Zika virus patients under their care.
What’s more, although 65% of the women surveyed were very concerned about the Zika virus, more than half of those considering getting pregnant would not delay pregnancy plans – under any circumstances.
Only one in four women reported that they are postponing any attempts to become pregnant, while 27% are reconsidering upcoming travel plans to certain regions in the United States.
“I don’t believe I’m at risk in the U.S.,” said one patient respondent.
Although Zika virus awareness among patients is high – 77% out of 629 prescreened women (including women not seeking to become pregnant) had heard news about the virus – precautionary behavior was not. A total of 56% of pregnant or would-be pregnant women surveyed said they currently use insect repellent, but nearly half are urging friends and family to take additional precautions to protect themselves against the Zika virus. And 20% of women said they aren’t taking any of the commonly considered precautions.
However, preparedness among doctors and hospitals, and U.S. government support for that, was an issue at the time physicians were surveyed on Feb. 3-5, 2016. Nearly half of the gynecologists and ob.gyns. responding said they do not feel prepared to treat a patient who has potentially contracted the disease. Only 34% of physicians reported that their hospitals have a Zika virus protocol. Those that do, have modified questionnaires to ask about recent travel, obtain blood for testing, and refer to CDC guidelines.
Although data werecaptured prior to the Obama administration’s $1.8 billion funding request to fight the virus, about half of both doctors and women surveyed moderately agreed that the U.S. government was taking strong precautions to prevent the spread of the Zika virus.
With data being obtained during the U.S. winter, when most mosquitoes hibernate, attitudes may be different come spring and summer.
InCrowd will track perceptions as this epidemic evolves. InCrowd’s mobile microsurvey captured data from 220 individuals, including 70 U.S.-based and triple-verified gynecologists or ob.gyns. with a minimum of 20 expectant patients, who as a group had an average of 100 expectant patients and 70 trying-to-get-expectant patients. The microsurvey also included 150 women between ages 18 and 45 surveyed between Feb. 5 and 7,2016, including 20% who were pregnant and 80% who were considering becoming pregnant.
Dr. Hayes has a PhD degree in epidemiology and is the president and cofounder of InCrowd, a tech market research company that provides real-time physician and patient insights to the life sciences industry.
A few weeks ago, Ob.Gyn. News contributor Dr. Eskild Petersen advocated for a calm, reasoned approach to the Zika virus despite a climate of fear amid headlines about higher microcephaly rates among infected women in South America and sexual transmission routes.
New data show that U.S. gynecologists and obstetrician-gynecologists, and perhaps more importantly, their pregnant, or seeking to become pregnant, patients are doing just that. They are clearly aware of and monitoring the Zika virus, but not overreacting to it.
In a microsurvey conducted by InCrowd, a provider of real-time market intelligence to life sciences and health care firms, gynecologists and ob.gyns. were sticking to rather low-tech and commonsense practices, rather than extraordinary measures, to avoid the Zika virus.
Although 90% of gynecologists and ob.gyns. surveyed were recommending against travel to affected countries while their patients are expecting or looking to become pregnant, the doctors’ primary recommendations were use of mosquito protection and reading of online bulletins from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists prior to travel. Only a third of these doctors would automatically test for the Zika virus if the patient had been to an affected area. Physicians anticipate they could actively manage as many as 10 cases of Zika virus patients under their care.
What’s more, although 65% of the women surveyed were very concerned about the Zika virus, more than half of those considering getting pregnant would not delay pregnancy plans – under any circumstances.
Only one in four women reported that they are postponing any attempts to become pregnant, while 27% are reconsidering upcoming travel plans to certain regions in the United States.
“I don’t believe I’m at risk in the U.S.,” said one patient respondent.
Although Zika virus awareness among patients is high – 77% out of 629 prescreened women (including women not seeking to become pregnant) had heard news about the virus – precautionary behavior was not. A total of 56% of pregnant or would-be pregnant women surveyed said they currently use insect repellent, but nearly half are urging friends and family to take additional precautions to protect themselves against the Zika virus. And 20% of women said they aren’t taking any of the commonly considered precautions.
However, preparedness among doctors and hospitals, and U.S. government support for that, was an issue at the time physicians were surveyed on Feb. 3-5, 2016. Nearly half of the gynecologists and ob.gyns. responding said they do not feel prepared to treat a patient who has potentially contracted the disease. Only 34% of physicians reported that their hospitals have a Zika virus protocol. Those that do, have modified questionnaires to ask about recent travel, obtain blood for testing, and refer to CDC guidelines.
Although data werecaptured prior to the Obama administration’s $1.8 billion funding request to fight the virus, about half of both doctors and women surveyed moderately agreed that the U.S. government was taking strong precautions to prevent the spread of the Zika virus.
With data being obtained during the U.S. winter, when most mosquitoes hibernate, attitudes may be different come spring and summer.
InCrowd will track perceptions as this epidemic evolves. InCrowd’s mobile microsurvey captured data from 220 individuals, including 70 U.S.-based and triple-verified gynecologists or ob.gyns. with a minimum of 20 expectant patients, who as a group had an average of 100 expectant patients and 70 trying-to-get-expectant patients. The microsurvey also included 150 women between ages 18 and 45 surveyed between Feb. 5 and 7,2016, including 20% who were pregnant and 80% who were considering becoming pregnant.
Dr. Hayes has a PhD degree in epidemiology and is the president and cofounder of InCrowd, a tech market research company that provides real-time physician and patient insights to the life sciences industry.
A few weeks ago, Ob.Gyn. News contributor Dr. Eskild Petersen advocated for a calm, reasoned approach to the Zika virus despite a climate of fear amid headlines about higher microcephaly rates among infected women in South America and sexual transmission routes.
New data show that U.S. gynecologists and obstetrician-gynecologists, and perhaps more importantly, their pregnant, or seeking to become pregnant, patients are doing just that. They are clearly aware of and monitoring the Zika virus, but not overreacting to it.
In a microsurvey conducted by InCrowd, a provider of real-time market intelligence to life sciences and health care firms, gynecologists and ob.gyns. were sticking to rather low-tech and commonsense practices, rather than extraordinary measures, to avoid the Zika virus.
Although 90% of gynecologists and ob.gyns. surveyed were recommending against travel to affected countries while their patients are expecting or looking to become pregnant, the doctors’ primary recommendations were use of mosquito protection and reading of online bulletins from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists prior to travel. Only a third of these doctors would automatically test for the Zika virus if the patient had been to an affected area. Physicians anticipate they could actively manage as many as 10 cases of Zika virus patients under their care.
What’s more, although 65% of the women surveyed were very concerned about the Zika virus, more than half of those considering getting pregnant would not delay pregnancy plans – under any circumstances.
Only one in four women reported that they are postponing any attempts to become pregnant, while 27% are reconsidering upcoming travel plans to certain regions in the United States.
“I don’t believe I’m at risk in the U.S.,” said one patient respondent.
Although Zika virus awareness among patients is high – 77% out of 629 prescreened women (including women not seeking to become pregnant) had heard news about the virus – precautionary behavior was not. A total of 56% of pregnant or would-be pregnant women surveyed said they currently use insect repellent, but nearly half are urging friends and family to take additional precautions to protect themselves against the Zika virus. And 20% of women said they aren’t taking any of the commonly considered precautions.
However, preparedness among doctors and hospitals, and U.S. government support for that, was an issue at the time physicians were surveyed on Feb. 3-5, 2016. Nearly half of the gynecologists and ob.gyns. responding said they do not feel prepared to treat a patient who has potentially contracted the disease. Only 34% of physicians reported that their hospitals have a Zika virus protocol. Those that do, have modified questionnaires to ask about recent travel, obtain blood for testing, and refer to CDC guidelines.
Although data werecaptured prior to the Obama administration’s $1.8 billion funding request to fight the virus, about half of both doctors and women surveyed moderately agreed that the U.S. government was taking strong precautions to prevent the spread of the Zika virus.
With data being obtained during the U.S. winter, when most mosquitoes hibernate, attitudes may be different come spring and summer.
InCrowd will track perceptions as this epidemic evolves. InCrowd’s mobile microsurvey captured data from 220 individuals, including 70 U.S.-based and triple-verified gynecologists or ob.gyns. with a minimum of 20 expectant patients, who as a group had an average of 100 expectant patients and 70 trying-to-get-expectant patients. The microsurvey also included 150 women between ages 18 and 45 surveyed between Feb. 5 and 7,2016, including 20% who were pregnant and 80% who were considering becoming pregnant.
Dr. Hayes has a PhD degree in epidemiology and is the president and cofounder of InCrowd, a tech market research company that provides real-time physician and patient insights to the life sciences industry.
The problem of office theft
Why do people steal stuff from my office?
I’m not talking about pens. I’ve unintentionally walked off with more pens then I can count over the years, and never realized that I did until later. I figure others do the same with mine.
In the last few years, I’ve had a Far Side cartoon book stolen from the lobby, a stapler off my secretary’s desk, a roll of medical tape from my EMG cart, and a few other items.
Most recently, my secretary bought a candy dish at the store. It was nothing fancy, just a few bucks, but she liked it. She set it out on the front desk with some Jolly Ranchers.
A few days later, she left her desk to refill her coffee cup. While in back she heard the front door of the office open and close. When she returned up front, the dish (and candy) were gone.
None of these are a major financial loss, maybe adding up to $15-$20 a year at most. But it’s irritating to have someone steal something minor from my office.
Taking pens, or even magazines, is perhaps understandable, at times unintentional. But to reach over a desk and grab a stapler, or to walk in, grab a candy dish, and leave, are volitional and just wrong. I don’t understand this. Do people feel that, because I’m a doctor (and therefore stereotyped as rich), I can afford it? Do they do it because, since they’re giving me a copay and letting me bill their insurance, they feel entitled to something back? Or are they angry at me over something, and this is a passive-aggressive way to get even?
I don’t know. Admittedly, it’s a tiny minority who do such things. The vast majority of people wouldn’t dream of stealing a $3 candy dish from an office. But still, it points to a sad level of dishonesty among a few of the routine people I see day in and day out. I’m pretty sure they aren’t so hard up that they need to steal such petty items, either. I imagine the black market value of a used stapler is pretty low.
P.S. If someone out there is willing to return the candy dish or the Beyond The Far Side cartoon book, no questions will be asked.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Why do people steal stuff from my office?
I’m not talking about pens. I’ve unintentionally walked off with more pens then I can count over the years, and never realized that I did until later. I figure others do the same with mine.
In the last few years, I’ve had a Far Side cartoon book stolen from the lobby, a stapler off my secretary’s desk, a roll of medical tape from my EMG cart, and a few other items.
Most recently, my secretary bought a candy dish at the store. It was nothing fancy, just a few bucks, but she liked it. She set it out on the front desk with some Jolly Ranchers.
A few days later, she left her desk to refill her coffee cup. While in back she heard the front door of the office open and close. When she returned up front, the dish (and candy) were gone.
None of these are a major financial loss, maybe adding up to $15-$20 a year at most. But it’s irritating to have someone steal something minor from my office.
Taking pens, or even magazines, is perhaps understandable, at times unintentional. But to reach over a desk and grab a stapler, or to walk in, grab a candy dish, and leave, are volitional and just wrong. I don’t understand this. Do people feel that, because I’m a doctor (and therefore stereotyped as rich), I can afford it? Do they do it because, since they’re giving me a copay and letting me bill their insurance, they feel entitled to something back? Or are they angry at me over something, and this is a passive-aggressive way to get even?
I don’t know. Admittedly, it’s a tiny minority who do such things. The vast majority of people wouldn’t dream of stealing a $3 candy dish from an office. But still, it points to a sad level of dishonesty among a few of the routine people I see day in and day out. I’m pretty sure they aren’t so hard up that they need to steal such petty items, either. I imagine the black market value of a used stapler is pretty low.
P.S. If someone out there is willing to return the candy dish or the Beyond The Far Side cartoon book, no questions will be asked.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
Why do people steal stuff from my office?
I’m not talking about pens. I’ve unintentionally walked off with more pens then I can count over the years, and never realized that I did until later. I figure others do the same with mine.
In the last few years, I’ve had a Far Side cartoon book stolen from the lobby, a stapler off my secretary’s desk, a roll of medical tape from my EMG cart, and a few other items.
Most recently, my secretary bought a candy dish at the store. It was nothing fancy, just a few bucks, but she liked it. She set it out on the front desk with some Jolly Ranchers.
A few days later, she left her desk to refill her coffee cup. While in back she heard the front door of the office open and close. When she returned up front, the dish (and candy) were gone.
None of these are a major financial loss, maybe adding up to $15-$20 a year at most. But it’s irritating to have someone steal something minor from my office.
Taking pens, or even magazines, is perhaps understandable, at times unintentional. But to reach over a desk and grab a stapler, or to walk in, grab a candy dish, and leave, are volitional and just wrong. I don’t understand this. Do people feel that, because I’m a doctor (and therefore stereotyped as rich), I can afford it? Do they do it because, since they’re giving me a copay and letting me bill their insurance, they feel entitled to something back? Or are they angry at me over something, and this is a passive-aggressive way to get even?
I don’t know. Admittedly, it’s a tiny minority who do such things. The vast majority of people wouldn’t dream of stealing a $3 candy dish from an office. But still, it points to a sad level of dishonesty among a few of the routine people I see day in and day out. I’m pretty sure they aren’t so hard up that they need to steal such petty items, either. I imagine the black market value of a used stapler is pretty low.
P.S. If someone out there is willing to return the candy dish or the Beyond The Far Side cartoon book, no questions will be asked.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
FDA made the right call on flibanserin
An article published on Feb. 29 in JAMA Internal Medicine and the associated editorial questioning the safety, efficacy, and approval of flibanserin are both factually inaccurate and misrepresent the large body of sound scientific data that led to approval by the Food and Drug Administration in August 2015.
Female sexual dysfunction is prevalent. About 40% of women experience low desire and 6%-10% meet criteria for the diagnosis of hypoactive sexual desire disorder (HSDD). The FDA established female sexual dysfunction as an area of unmet medical need. HSDD has a clear, scientifically proven biologic basis. It causes women distress, and often affects a woman’s quality of life and her relationships. We have tools to diagnose HSDD in our office, and finally, we have the first-ever, FDA-approved treatment option for women. The FDA made the correct decision to approve flibanserin based on a careful review of the scientific data.
Flibanserin was approved based on the results of three pivotal trials in more than 11,000 patients documenting statistically significant improvement in sexually satisfying events, improvement in desire, and decrease in distress. As with all FDA-approved medications, flibanserin has side effects and drug interactions, but these are similar to, and in fact less severe than the side effects and drug interactions of other medications, including commonly prescribed antidepressants. The authors correctly conclude that the adverse events in the trials are mild and “reflects positively on the safety of flibanserin” (JAMA Intern Med. 2016 Feb 29. doi: 10.1001/jamainternmed.2015.8565).
It should be noted that flibanserin is similar in effectiveness and side effects to many other FDA-approved medications that work on brain neurotransmitters, such as antidepressants. As with other antidepressants, flibanserin is not effective in all women. The editorial’s claim that 90% of treated patients do not respond is factually inaccurate. The data in the pivotal trials demonstrate that 40%-50% of women respond with on average 2.5-4 additional sexually satisfying events over placebo. More significantly, 25% of responders had more than four additional sexually satisfying events per month. The author’s statement that the increase in sexually satisfying events was 0.5 per month is misleading because it includes nonresponders, and data with lower doses of flibanserin that are not effective.
Women are smart and are capable of understanding scientific data about medications including potential risks and potential benefits and of making informed treatment decisions.
I direct a menopause and sexual health clinic, and have prescribed flibanserin to approximately 15 premenopausal women with diagnosed acquired, generalized HSDD over the last 4 months after discussion of the data, the interaction with alcohol, drug interactions, and potential side effects. Similar to the reported data, approximately half of those women have had a robust response. None of the women have had significant side effects. All of the responders have continued the medication. Nonresponders all discontinued the medication after 8 weeks with no untoward effects.
I continue to discuss risk and benefit, and potential adverse effects with all women who remain on the drug in the same way I discuss risk and benefit with ongoing hormone therapy in postmenopausal women.
Prior to the FDA approval of flibanserin, women suffering with HSDD had only untested, unstudied compounded and off-label treatment options with unproven benefits and uncertain risks. Now with an FDA-approved product, patients can be confident about the dose and purity of medication, and are fully informed about the possible side effects and drug interactions as documented in a package insert. For this reason, I view flibanserin as a safer alternative for my patients with HSDD.
Finally, I take issue with the statement in the editorial that “the FDA approved a marginally effective drug for a non–life-threatening condition in the face of substantial – and unnecessary – uncertainty about its dangers” (JAMA Intern Med. 2016 Feb 29. doi: 10.1001/jamainternmed.2016.0073). That statement is a gross misrepresentation of the data and the FDA approval process. I was at the FDA when flibanserin was approved, and the FDA approval came after a careful and exhaustive review of the data. Give the FDA the credit it is due for doing the right thing for women based on science, not politics.
Dr. Larkin is director of the UC Health Women’s Center, Cincinnati; advocacy chair and a board member of the International Society for the Study of Women’s Sexual Health; and scientific chair of Even the Score. She reported one-time advisory work in 2016 for Valeant, the manufacturer of flibanserin.
An article published on Feb. 29 in JAMA Internal Medicine and the associated editorial questioning the safety, efficacy, and approval of flibanserin are both factually inaccurate and misrepresent the large body of sound scientific data that led to approval by the Food and Drug Administration in August 2015.
Female sexual dysfunction is prevalent. About 40% of women experience low desire and 6%-10% meet criteria for the diagnosis of hypoactive sexual desire disorder (HSDD). The FDA established female sexual dysfunction as an area of unmet medical need. HSDD has a clear, scientifically proven biologic basis. It causes women distress, and often affects a woman’s quality of life and her relationships. We have tools to diagnose HSDD in our office, and finally, we have the first-ever, FDA-approved treatment option for women. The FDA made the correct decision to approve flibanserin based on a careful review of the scientific data.
Flibanserin was approved based on the results of three pivotal trials in more than 11,000 patients documenting statistically significant improvement in sexually satisfying events, improvement in desire, and decrease in distress. As with all FDA-approved medications, flibanserin has side effects and drug interactions, but these are similar to, and in fact less severe than the side effects and drug interactions of other medications, including commonly prescribed antidepressants. The authors correctly conclude that the adverse events in the trials are mild and “reflects positively on the safety of flibanserin” (JAMA Intern Med. 2016 Feb 29. doi: 10.1001/jamainternmed.2015.8565).
It should be noted that flibanserin is similar in effectiveness and side effects to many other FDA-approved medications that work on brain neurotransmitters, such as antidepressants. As with other antidepressants, flibanserin is not effective in all women. The editorial’s claim that 90% of treated patients do not respond is factually inaccurate. The data in the pivotal trials demonstrate that 40%-50% of women respond with on average 2.5-4 additional sexually satisfying events over placebo. More significantly, 25% of responders had more than four additional sexually satisfying events per month. The author’s statement that the increase in sexually satisfying events was 0.5 per month is misleading because it includes nonresponders, and data with lower doses of flibanserin that are not effective.
Women are smart and are capable of understanding scientific data about medications including potential risks and potential benefits and of making informed treatment decisions.
I direct a menopause and sexual health clinic, and have prescribed flibanserin to approximately 15 premenopausal women with diagnosed acquired, generalized HSDD over the last 4 months after discussion of the data, the interaction with alcohol, drug interactions, and potential side effects. Similar to the reported data, approximately half of those women have had a robust response. None of the women have had significant side effects. All of the responders have continued the medication. Nonresponders all discontinued the medication after 8 weeks with no untoward effects.
I continue to discuss risk and benefit, and potential adverse effects with all women who remain on the drug in the same way I discuss risk and benefit with ongoing hormone therapy in postmenopausal women.
Prior to the FDA approval of flibanserin, women suffering with HSDD had only untested, unstudied compounded and off-label treatment options with unproven benefits and uncertain risks. Now with an FDA-approved product, patients can be confident about the dose and purity of medication, and are fully informed about the possible side effects and drug interactions as documented in a package insert. For this reason, I view flibanserin as a safer alternative for my patients with HSDD.
Finally, I take issue with the statement in the editorial that “the FDA approved a marginally effective drug for a non–life-threatening condition in the face of substantial – and unnecessary – uncertainty about its dangers” (JAMA Intern Med. 2016 Feb 29. doi: 10.1001/jamainternmed.2016.0073). That statement is a gross misrepresentation of the data and the FDA approval process. I was at the FDA when flibanserin was approved, and the FDA approval came after a careful and exhaustive review of the data. Give the FDA the credit it is due for doing the right thing for women based on science, not politics.
Dr. Larkin is director of the UC Health Women’s Center, Cincinnati; advocacy chair and a board member of the International Society for the Study of Women’s Sexual Health; and scientific chair of Even the Score. She reported one-time advisory work in 2016 for Valeant, the manufacturer of flibanserin.
An article published on Feb. 29 in JAMA Internal Medicine and the associated editorial questioning the safety, efficacy, and approval of flibanserin are both factually inaccurate and misrepresent the large body of sound scientific data that led to approval by the Food and Drug Administration in August 2015.
Female sexual dysfunction is prevalent. About 40% of women experience low desire and 6%-10% meet criteria for the diagnosis of hypoactive sexual desire disorder (HSDD). The FDA established female sexual dysfunction as an area of unmet medical need. HSDD has a clear, scientifically proven biologic basis. It causes women distress, and often affects a woman’s quality of life and her relationships. We have tools to diagnose HSDD in our office, and finally, we have the first-ever, FDA-approved treatment option for women. The FDA made the correct decision to approve flibanserin based on a careful review of the scientific data.
Flibanserin was approved based on the results of three pivotal trials in more than 11,000 patients documenting statistically significant improvement in sexually satisfying events, improvement in desire, and decrease in distress. As with all FDA-approved medications, flibanserin has side effects and drug interactions, but these are similar to, and in fact less severe than the side effects and drug interactions of other medications, including commonly prescribed antidepressants. The authors correctly conclude that the adverse events in the trials are mild and “reflects positively on the safety of flibanserin” (JAMA Intern Med. 2016 Feb 29. doi: 10.1001/jamainternmed.2015.8565).
It should be noted that flibanserin is similar in effectiveness and side effects to many other FDA-approved medications that work on brain neurotransmitters, such as antidepressants. As with other antidepressants, flibanserin is not effective in all women. The editorial’s claim that 90% of treated patients do not respond is factually inaccurate. The data in the pivotal trials demonstrate that 40%-50% of women respond with on average 2.5-4 additional sexually satisfying events over placebo. More significantly, 25% of responders had more than four additional sexually satisfying events per month. The author’s statement that the increase in sexually satisfying events was 0.5 per month is misleading because it includes nonresponders, and data with lower doses of flibanserin that are not effective.
Women are smart and are capable of understanding scientific data about medications including potential risks and potential benefits and of making informed treatment decisions.
I direct a menopause and sexual health clinic, and have prescribed flibanserin to approximately 15 premenopausal women with diagnosed acquired, generalized HSDD over the last 4 months after discussion of the data, the interaction with alcohol, drug interactions, and potential side effects. Similar to the reported data, approximately half of those women have had a robust response. None of the women have had significant side effects. All of the responders have continued the medication. Nonresponders all discontinued the medication after 8 weeks with no untoward effects.
I continue to discuss risk and benefit, and potential adverse effects with all women who remain on the drug in the same way I discuss risk and benefit with ongoing hormone therapy in postmenopausal women.
Prior to the FDA approval of flibanserin, women suffering with HSDD had only untested, unstudied compounded and off-label treatment options with unproven benefits and uncertain risks. Now with an FDA-approved product, patients can be confident about the dose and purity of medication, and are fully informed about the possible side effects and drug interactions as documented in a package insert. For this reason, I view flibanserin as a safer alternative for my patients with HSDD.
Finally, I take issue with the statement in the editorial that “the FDA approved a marginally effective drug for a non–life-threatening condition in the face of substantial – and unnecessary – uncertainty about its dangers” (JAMA Intern Med. 2016 Feb 29. doi: 10.1001/jamainternmed.2016.0073). That statement is a gross misrepresentation of the data and the FDA approval process. I was at the FDA when flibanserin was approved, and the FDA approval came after a careful and exhaustive review of the data. Give the FDA the credit it is due for doing the right thing for women based on science, not politics.
Dr. Larkin is director of the UC Health Women’s Center, Cincinnati; advocacy chair and a board member of the International Society for the Study of Women’s Sexual Health; and scientific chair of Even the Score. She reported one-time advisory work in 2016 for Valeant, the manufacturer of flibanserin.
EHR Report: How Zika virus reveals the fault in our EHRs
It is always noteworthy when the headlines in the medical and mainstream media appear to be the same.
Typically, this means one of two things: 1) Sensationalism has propelled a minor issue into the common lexicon; or 2) a truly serious issue has grown to the point where the whole world is finally taking notice.
With the recent resurgence of Zika virus, something that initially seemed to be the former has unmistakably developed into the latter, and health care providers are again facing an age-old question: How do we adequately fight an evolving and serious illness in the midst of an ever-changing battlefield?
As has been the case countless times before, the answer to this question really lies in early identification. One might think that the advent of modern technology would make this a much easier proposition, but that has not exactly been the case.
In fact, recent Ebola and Zika outbreaks have actually served to demonstrate a big problem in many modern electronic health records: poor clinical decision support.
In this column, we felt it would be helpful to highlight this shortcoming, and make the suggestion that in the world of EHRs …
Change needs to be faster than Zika
Zika virus is not new (it was first identified in the Zika Forest of Uganda in 1947), and neither is the concept of serious mosquito-born illness. While the current Zika hot zones are South America, Central America, Mexico, and the Caribbean, case reports indicate the virus is quickly migrating. At the time of this writing, more than 150 travel-associated cases of Zika have been identified in the continental United States, and it is clear that the consequences of undiagnosed Zika in pregnancy can be devastating.
Furthermore, Zika is just the latest of many viruses to threaten the health and welfare of modern civilization (for example, Ebola, swine flu, SARS, and so on), so screening and prevention is far from a novel idea.
Unfortunately, electronic record vendors don’t seem to have gotten the message that the ability to adapt quickly to public health threats should be a core element of any modern EHR.
On the contrary, EHRs seem to be designed for fixed “best practice” workflows, and updates are often slow in coming (typically requiring a major upgrade or “patch”). This renders them fairly unable to react nimbly to change.
This fact became evident to us as we attempted to implement a reminder for staff members to perform a Zika-focused travel history on all patients. We felt it was critical for this reminder to be prominent, be easy to interact with, and appear at the most appropriate time for screening.
Despite multiple attempts, we discovered that our top-ranked, industry-leading EHR was unable to do this seemingly straightforward task, and eventually we reverted to the age-old practice of hanging signs in all of the exam rooms. These encouraged patients to inform their doctor “of worrisome symptoms or recent travel history to affected areas.”
We refuse to accept the inability of any modern electronic health record to create simple and flexible clinical support rules and improve on the efficacy of the paper sign. This, especially in light of the fact that one of the core requirements of the Meaningful Use (MU) program – for which all EHRs are certified – is clinical decision support!
Unfortunately, the MU guidelines are not specific, so most vendors choose to include a standard set of rules and don’t allow the ability for customization. That just isn’t good enough. If Ebola and Zika have taught the health information technology community one thing, it’s that …
It is time for smarter EHRs!
For many people, the notion of artificial intelligence seems to be science fiction, but they don’t realize they are carrying incredible “AI” devices with them everywhere they go. We are, of course, referring to our cell phones, which seem to be getting more intelligent all the time.
If you own an iPhone, you may have noticed it often seems to know where you are about to drive and how long it will take you to get there. This can be a bit creepy at first, until you realize how helpful – and smart – it actually is.
Essentially, our devices are constantly collecting data, reading the patterns of our lives, and learning ways to enhance them. Smartphones have revolutionized how we communicate, work, and play. Why, then, can’t our electronic health record software do the same?
It will surprise exactly none of our readers that the Meaningful Use program has fallen short of its goal of promoting the true benefits of electronic records. Many critics have suggested that the incentive program has faltered because EHRs have made physicians work harder, without helping them work smarter.
Zika virus proves the critics correct. Beyond creating just simple reminders as mentioned above, EHRs should be able to make intelligent suggestions based on patient data and current practice guidelines.
Some EHRs get it half correct. For example, they are “smart” enough to remind clinicians that women of a certain age should have mammograms, but they fall short in the ability to efficiently update those reminders when the U.S. Preventive Services Task Force updates the screening recommendation (as they did recently).
Other EHRs do allow you to customize preventative health reminders, but do not place them in a position of prominence – so they are easily overlooked by providers as they care for patients.
Few products seem to get it just right, and it’s time for this to change.
Simply put, as questions in the media loom about how to stop this rising threat, we as frontline health care providers should have the tools – and the decision support – required to provide meaningful answers.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
It is always noteworthy when the headlines in the medical and mainstream media appear to be the same.
Typically, this means one of two things: 1) Sensationalism has propelled a minor issue into the common lexicon; or 2) a truly serious issue has grown to the point where the whole world is finally taking notice.
With the recent resurgence of Zika virus, something that initially seemed to be the former has unmistakably developed into the latter, and health care providers are again facing an age-old question: How do we adequately fight an evolving and serious illness in the midst of an ever-changing battlefield?
As has been the case countless times before, the answer to this question really lies in early identification. One might think that the advent of modern technology would make this a much easier proposition, but that has not exactly been the case.
In fact, recent Ebola and Zika outbreaks have actually served to demonstrate a big problem in many modern electronic health records: poor clinical decision support.
In this column, we felt it would be helpful to highlight this shortcoming, and make the suggestion that in the world of EHRs …
Change needs to be faster than Zika
Zika virus is not new (it was first identified in the Zika Forest of Uganda in 1947), and neither is the concept of serious mosquito-born illness. While the current Zika hot zones are South America, Central America, Mexico, and the Caribbean, case reports indicate the virus is quickly migrating. At the time of this writing, more than 150 travel-associated cases of Zika have been identified in the continental United States, and it is clear that the consequences of undiagnosed Zika in pregnancy can be devastating.
Furthermore, Zika is just the latest of many viruses to threaten the health and welfare of modern civilization (for example, Ebola, swine flu, SARS, and so on), so screening and prevention is far from a novel idea.
Unfortunately, electronic record vendors don’t seem to have gotten the message that the ability to adapt quickly to public health threats should be a core element of any modern EHR.
On the contrary, EHRs seem to be designed for fixed “best practice” workflows, and updates are often slow in coming (typically requiring a major upgrade or “patch”). This renders them fairly unable to react nimbly to change.
This fact became evident to us as we attempted to implement a reminder for staff members to perform a Zika-focused travel history on all patients. We felt it was critical for this reminder to be prominent, be easy to interact with, and appear at the most appropriate time for screening.
Despite multiple attempts, we discovered that our top-ranked, industry-leading EHR was unable to do this seemingly straightforward task, and eventually we reverted to the age-old practice of hanging signs in all of the exam rooms. These encouraged patients to inform their doctor “of worrisome symptoms or recent travel history to affected areas.”
We refuse to accept the inability of any modern electronic health record to create simple and flexible clinical support rules and improve on the efficacy of the paper sign. This, especially in light of the fact that one of the core requirements of the Meaningful Use (MU) program – for which all EHRs are certified – is clinical decision support!
Unfortunately, the MU guidelines are not specific, so most vendors choose to include a standard set of rules and don’t allow the ability for customization. That just isn’t good enough. If Ebola and Zika have taught the health information technology community one thing, it’s that …
It is time for smarter EHRs!
For many people, the notion of artificial intelligence seems to be science fiction, but they don’t realize they are carrying incredible “AI” devices with them everywhere they go. We are, of course, referring to our cell phones, which seem to be getting more intelligent all the time.
If you own an iPhone, you may have noticed it often seems to know where you are about to drive and how long it will take you to get there. This can be a bit creepy at first, until you realize how helpful – and smart – it actually is.
Essentially, our devices are constantly collecting data, reading the patterns of our lives, and learning ways to enhance them. Smartphones have revolutionized how we communicate, work, and play. Why, then, can’t our electronic health record software do the same?
It will surprise exactly none of our readers that the Meaningful Use program has fallen short of its goal of promoting the true benefits of electronic records. Many critics have suggested that the incentive program has faltered because EHRs have made physicians work harder, without helping them work smarter.
Zika virus proves the critics correct. Beyond creating just simple reminders as mentioned above, EHRs should be able to make intelligent suggestions based on patient data and current practice guidelines.
Some EHRs get it half correct. For example, they are “smart” enough to remind clinicians that women of a certain age should have mammograms, but they fall short in the ability to efficiently update those reminders when the U.S. Preventive Services Task Force updates the screening recommendation (as they did recently).
Other EHRs do allow you to customize preventative health reminders, but do not place them in a position of prominence – so they are easily overlooked by providers as they care for patients.
Few products seem to get it just right, and it’s time for this to change.
Simply put, as questions in the media loom about how to stop this rising threat, we as frontline health care providers should have the tools – and the decision support – required to provide meaningful answers.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
It is always noteworthy when the headlines in the medical and mainstream media appear to be the same.
Typically, this means one of two things: 1) Sensationalism has propelled a minor issue into the common lexicon; or 2) a truly serious issue has grown to the point where the whole world is finally taking notice.
With the recent resurgence of Zika virus, something that initially seemed to be the former has unmistakably developed into the latter, and health care providers are again facing an age-old question: How do we adequately fight an evolving and serious illness in the midst of an ever-changing battlefield?
As has been the case countless times before, the answer to this question really lies in early identification. One might think that the advent of modern technology would make this a much easier proposition, but that has not exactly been the case.
In fact, recent Ebola and Zika outbreaks have actually served to demonstrate a big problem in many modern electronic health records: poor clinical decision support.
In this column, we felt it would be helpful to highlight this shortcoming, and make the suggestion that in the world of EHRs …
Change needs to be faster than Zika
Zika virus is not new (it was first identified in the Zika Forest of Uganda in 1947), and neither is the concept of serious mosquito-born illness. While the current Zika hot zones are South America, Central America, Mexico, and the Caribbean, case reports indicate the virus is quickly migrating. At the time of this writing, more than 150 travel-associated cases of Zika have been identified in the continental United States, and it is clear that the consequences of undiagnosed Zika in pregnancy can be devastating.
Furthermore, Zika is just the latest of many viruses to threaten the health and welfare of modern civilization (for example, Ebola, swine flu, SARS, and so on), so screening and prevention is far from a novel idea.
Unfortunately, electronic record vendors don’t seem to have gotten the message that the ability to adapt quickly to public health threats should be a core element of any modern EHR.
On the contrary, EHRs seem to be designed for fixed “best practice” workflows, and updates are often slow in coming (typically requiring a major upgrade or “patch”). This renders them fairly unable to react nimbly to change.
This fact became evident to us as we attempted to implement a reminder for staff members to perform a Zika-focused travel history on all patients. We felt it was critical for this reminder to be prominent, be easy to interact with, and appear at the most appropriate time for screening.
Despite multiple attempts, we discovered that our top-ranked, industry-leading EHR was unable to do this seemingly straightforward task, and eventually we reverted to the age-old practice of hanging signs in all of the exam rooms. These encouraged patients to inform their doctor “of worrisome symptoms or recent travel history to affected areas.”
We refuse to accept the inability of any modern electronic health record to create simple and flexible clinical support rules and improve on the efficacy of the paper sign. This, especially in light of the fact that one of the core requirements of the Meaningful Use (MU) program – for which all EHRs are certified – is clinical decision support!
Unfortunately, the MU guidelines are not specific, so most vendors choose to include a standard set of rules and don’t allow the ability for customization. That just isn’t good enough. If Ebola and Zika have taught the health information technology community one thing, it’s that …
It is time for smarter EHRs!
For many people, the notion of artificial intelligence seems to be science fiction, but they don’t realize they are carrying incredible “AI” devices with them everywhere they go. We are, of course, referring to our cell phones, which seem to be getting more intelligent all the time.
If you own an iPhone, you may have noticed it often seems to know where you are about to drive and how long it will take you to get there. This can be a bit creepy at first, until you realize how helpful – and smart – it actually is.
Essentially, our devices are constantly collecting data, reading the patterns of our lives, and learning ways to enhance them. Smartphones have revolutionized how we communicate, work, and play. Why, then, can’t our electronic health record software do the same?
It will surprise exactly none of our readers that the Meaningful Use program has fallen short of its goal of promoting the true benefits of electronic records. Many critics have suggested that the incentive program has faltered because EHRs have made physicians work harder, without helping them work smarter.
Zika virus proves the critics correct. Beyond creating just simple reminders as mentioned above, EHRs should be able to make intelligent suggestions based on patient data and current practice guidelines.
Some EHRs get it half correct. For example, they are “smart” enough to remind clinicians that women of a certain age should have mammograms, but they fall short in the ability to efficiently update those reminders when the U.S. Preventive Services Task Force updates the screening recommendation (as they did recently).
Other EHRs do allow you to customize preventative health reminders, but do not place them in a position of prominence – so they are easily overlooked by providers as they care for patients.
Few products seem to get it just right, and it’s time for this to change.
Simply put, as questions in the media loom about how to stop this rising threat, we as frontline health care providers should have the tools – and the decision support – required to provide meaningful answers.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is associate director of the family medicine residency program at Abington Memorial Hospital and professor of family and community medicine at Temple University in Philadelphia.
Is It Possible to Be More Productive in Less Time?
Raise your hand if you join me in becoming increasingly annoyed at the following instruction: “Don’t work harder (or longer), work smarter.” Despite this admonition, I am working more intensively and spending more hours working than ever before. My friends in a variety of occupations and my colleagues at my institution are too. It is not just a mirage; from 1970 to 2000, average workers in the United States added nearly 200 hours of work per year to their schedules.1 That’s a whole extra month! And this is not just logging more hours at work. These hours also are more hectic with fewer breaks and many more demands. Unfortunately, more hours at work does not necessarily translate into getting more work done. There is good evidence to show that once our working day stretches beyond 8 hours, our cognitive performance and our productivity decline.2,3
I am feeling the squeeze, and I know you are too. Is it possible to be more productive in less time? In the reading I did to answer this question I found 4 major themes: (1) single task, (2) plan downtime, (3) schedule priorities, and (4) manage procrastination.
As a full-time clinician and a single mother with 4 children, a dog, 2 cats, and a house, I admire those who can multitask; however, experts now conclude that multitasking is not productive. People doing 2 tasks at once took up to 30% longer and made twice as many errors as those who completed the same tasks in sequence.4 Frequent interruptions had the same effect. A study found it took employees 15 minutes to fully regain their train of thought after they were interrupted by an email, even if they did not reply to the email.5 Instant messages produced a lag of 10 minutes. In addition, habitual multitaskers take longer to switch between tasks, probably because of losing the ability to focus.6 Those of us who think we are great multitaskers are the worst at it.7 The ping of the new email or text is exciting and can become addictive. To counteract the interruptions, batch up related tasks (eg, electronic medical records in-box, emails, telephone calls) and remove distractions. Smartphones can be programmed to announce loudly and specifically when our 12-year-old child texts but not announce other texts and calls that can be retrieved later. Slip a small notebook in your pocket or use your smartphone to record free-floating ideas to come back to at another time.
As soon as we wake up in the morning, we start making decisions. Some of the simple moment-to-moment choices have been automated; most of us rarely have to decide to brush our teeth or make coffee. Then a day of constant decision-making starts, which means finding options, evaluating the pros and cons, comparing the possible sequelae, and then determining a course of action. The more decisions we ask our brain to make, the less able we are to concentrate and make nuanced assessments, and the more our decisions exhibit less insight and forward thinking.8,9 However, rest periods improve task performance. As seen in brain imaging studies, rest allows the brain to continue processing and set up new connections.10 To prevent decision fatigue, plan downtime even if it is for just a few minutes of deep breathing or stretching against the wall every 90 minutes or less. An ideal time is between batches of tasks. Longer reflection time after a meeting is key before the next activity, solidifying the events of the meeting.
I know that on the occasions when I get up in the morning and focus on what is most important to do that day, I generally get it done, as well as other items on my to-do list. If I made prioritizing and planning a deliberate daily habit, it would allow for much greater productivity. It often is recommended that a list be made of all the activities and tasks to be done that day or week and then to compare it to a list of primary goals. Pay attention to the important items and not just the urgent ones. Urgent items can fill up the day but some of them may have little relationship to our primary goals. Those that are urgent but not important can be delegated, deferred, or even purged. Rank the important tasks and schedule the highest priority in defined blocks. This kind of deliberate prioritizing requires repeated monitoring and revisiting of goals and tasks but ensures that what is most important gets done.
Most physicians are perfectionists, which can be a good thing. I want my doctor to be a perfectionist when he/she is examining me or writing me a prescription. But perfectionism also has a high price. It makes delegation of a task difficult because of the perception that the other person might not do the task as well as you can. It also can cause us to put off doing a task because we do not have enough time now to do it well enough. Later we feel stressed because it is still undone, and then we panic and become overwhelmed at the thought of tackling this task, which now has an even bigger emotional load. Being productive means learning to manage procrastination. Brian Tracy has 21 great ways to stop procrastination in his book Eat That Frog,11 but you really only need 3 of his rules: (1) If you have to eat a frog, eat it first thing in the morning. (2) If you have to eat 2 frogs, eat the bigger one first. (3) If the frog is too big to eat, cut it into bite-size pieces.
Will it ever be possible for me to do the same amount of work in less time and feel good about it? I am not sure. However, I have become convinced that I can end each day satisfied with the tasks I was able to accomplish if I develop the habits of single tasking, planning downtime, scheduling priorities, and managing procrastination. I hope these tools will also help you find the same satisfaction.
1. Schor J. The (even more) overworked American. In: de Graaf J, ed. Take Back Your Time: Fighting Overwork and Time Poverty in America. San Francisco, CA: Berrett- Koehler; 2003:7.
2. Virtanen M, Singh-Manoux A, Ferrie JE, et al. Long working hours and cognitive function: the Whitehall II Study. Am J Epidemiol. 2009;169:596-605.
3. Labour productivity levels in the total economy. Organisation for Economic Co-operation and Development website. http://stats.oecd.org/Index.aspx?DatasetCode=LEVEL#. Accessed Feb 17, 2016.
4. Dux PE, Ivanoff J, Asplund CL, et al. Isolation of a central bottleneck of information processing with time-resolved FMRI. Neuron. 2006;52:1109-1120.
5. Iqbal ST, Horvitz E. Disruption and recovery of computing tasks: field study, analysis, and directions. Paper presented at: Computer/Human Interaction 2007 Conference; April 28-May 3, 2007; San Jose, CA.
6. Ophir E, Nass C, Wagner AD. Cognitive control in media multitaskers. Proc Natl Acad Sci U S A. 2009;106:15583-15587.
7. Sanbonmatsu DM, Strayer DL, Medeiros-Ward N, et al. Who multi-tasks and why? multi-tasking ability, perceived multi-tasking ability, impulsivity, and sensation seeking. PLoS One. 2013;8:e54402.
8. Danzinger S, Levav J, Avnaim-Pesso L. Extraneous factors in judicial decisions. Proc Natl Acad Sci U S A. 2011;108:6889-6892.
9. Dai H, Milkman KL, Hofmann DA, et al. The impact of time at work and time off from work on rule compliance: the case of hand hygiene in health care. J Appl Psychol. 2015;100:846-862.
10. Sami S, Robertson EM, Miall RC. The time course of task-specific memory consolidation effects in resting state networks. J Neurosci. 2014;34:3982-3992.
11. Tracy B. Eat That Frog! 21 Ways to Stop Procrastinating and Get More Done in Less Time. 2nd ed. San Francisco, CA: Berrett-Koehler Publishers; 2007.
Raise your hand if you join me in becoming increasingly annoyed at the following instruction: “Don’t work harder (or longer), work smarter.” Despite this admonition, I am working more intensively and spending more hours working than ever before. My friends in a variety of occupations and my colleagues at my institution are too. It is not just a mirage; from 1970 to 2000, average workers in the United States added nearly 200 hours of work per year to their schedules.1 That’s a whole extra month! And this is not just logging more hours at work. These hours also are more hectic with fewer breaks and many more demands. Unfortunately, more hours at work does not necessarily translate into getting more work done. There is good evidence to show that once our working day stretches beyond 8 hours, our cognitive performance and our productivity decline.2,3
I am feeling the squeeze, and I know you are too. Is it possible to be more productive in less time? In the reading I did to answer this question I found 4 major themes: (1) single task, (2) plan downtime, (3) schedule priorities, and (4) manage procrastination.
As a full-time clinician and a single mother with 4 children, a dog, 2 cats, and a house, I admire those who can multitask; however, experts now conclude that multitasking is not productive. People doing 2 tasks at once took up to 30% longer and made twice as many errors as those who completed the same tasks in sequence.4 Frequent interruptions had the same effect. A study found it took employees 15 minutes to fully regain their train of thought after they were interrupted by an email, even if they did not reply to the email.5 Instant messages produced a lag of 10 minutes. In addition, habitual multitaskers take longer to switch between tasks, probably because of losing the ability to focus.6 Those of us who think we are great multitaskers are the worst at it.7 The ping of the new email or text is exciting and can become addictive. To counteract the interruptions, batch up related tasks (eg, electronic medical records in-box, emails, telephone calls) and remove distractions. Smartphones can be programmed to announce loudly and specifically when our 12-year-old child texts but not announce other texts and calls that can be retrieved later. Slip a small notebook in your pocket or use your smartphone to record free-floating ideas to come back to at another time.
As soon as we wake up in the morning, we start making decisions. Some of the simple moment-to-moment choices have been automated; most of us rarely have to decide to brush our teeth or make coffee. Then a day of constant decision-making starts, which means finding options, evaluating the pros and cons, comparing the possible sequelae, and then determining a course of action. The more decisions we ask our brain to make, the less able we are to concentrate and make nuanced assessments, and the more our decisions exhibit less insight and forward thinking.8,9 However, rest periods improve task performance. As seen in brain imaging studies, rest allows the brain to continue processing and set up new connections.10 To prevent decision fatigue, plan downtime even if it is for just a few minutes of deep breathing or stretching against the wall every 90 minutes or less. An ideal time is between batches of tasks. Longer reflection time after a meeting is key before the next activity, solidifying the events of the meeting.
I know that on the occasions when I get up in the morning and focus on what is most important to do that day, I generally get it done, as well as other items on my to-do list. If I made prioritizing and planning a deliberate daily habit, it would allow for much greater productivity. It often is recommended that a list be made of all the activities and tasks to be done that day or week and then to compare it to a list of primary goals. Pay attention to the important items and not just the urgent ones. Urgent items can fill up the day but some of them may have little relationship to our primary goals. Those that are urgent but not important can be delegated, deferred, or even purged. Rank the important tasks and schedule the highest priority in defined blocks. This kind of deliberate prioritizing requires repeated monitoring and revisiting of goals and tasks but ensures that what is most important gets done.
Most physicians are perfectionists, which can be a good thing. I want my doctor to be a perfectionist when he/she is examining me or writing me a prescription. But perfectionism also has a high price. It makes delegation of a task difficult because of the perception that the other person might not do the task as well as you can. It also can cause us to put off doing a task because we do not have enough time now to do it well enough. Later we feel stressed because it is still undone, and then we panic and become overwhelmed at the thought of tackling this task, which now has an even bigger emotional load. Being productive means learning to manage procrastination. Brian Tracy has 21 great ways to stop procrastination in his book Eat That Frog,11 but you really only need 3 of his rules: (1) If you have to eat a frog, eat it first thing in the morning. (2) If you have to eat 2 frogs, eat the bigger one first. (3) If the frog is too big to eat, cut it into bite-size pieces.
Will it ever be possible for me to do the same amount of work in less time and feel good about it? I am not sure. However, I have become convinced that I can end each day satisfied with the tasks I was able to accomplish if I develop the habits of single tasking, planning downtime, scheduling priorities, and managing procrastination. I hope these tools will also help you find the same satisfaction.
Raise your hand if you join me in becoming increasingly annoyed at the following instruction: “Don’t work harder (or longer), work smarter.” Despite this admonition, I am working more intensively and spending more hours working than ever before. My friends in a variety of occupations and my colleagues at my institution are too. It is not just a mirage; from 1970 to 2000, average workers in the United States added nearly 200 hours of work per year to their schedules.1 That’s a whole extra month! And this is not just logging more hours at work. These hours also are more hectic with fewer breaks and many more demands. Unfortunately, more hours at work does not necessarily translate into getting more work done. There is good evidence to show that once our working day stretches beyond 8 hours, our cognitive performance and our productivity decline.2,3
I am feeling the squeeze, and I know you are too. Is it possible to be more productive in less time? In the reading I did to answer this question I found 4 major themes: (1) single task, (2) plan downtime, (3) schedule priorities, and (4) manage procrastination.
As a full-time clinician and a single mother with 4 children, a dog, 2 cats, and a house, I admire those who can multitask; however, experts now conclude that multitasking is not productive. People doing 2 tasks at once took up to 30% longer and made twice as many errors as those who completed the same tasks in sequence.4 Frequent interruptions had the same effect. A study found it took employees 15 minutes to fully regain their train of thought after they were interrupted by an email, even if they did not reply to the email.5 Instant messages produced a lag of 10 minutes. In addition, habitual multitaskers take longer to switch between tasks, probably because of losing the ability to focus.6 Those of us who think we are great multitaskers are the worst at it.7 The ping of the new email or text is exciting and can become addictive. To counteract the interruptions, batch up related tasks (eg, electronic medical records in-box, emails, telephone calls) and remove distractions. Smartphones can be programmed to announce loudly and specifically when our 12-year-old child texts but not announce other texts and calls that can be retrieved later. Slip a small notebook in your pocket or use your smartphone to record free-floating ideas to come back to at another time.
As soon as we wake up in the morning, we start making decisions. Some of the simple moment-to-moment choices have been automated; most of us rarely have to decide to brush our teeth or make coffee. Then a day of constant decision-making starts, which means finding options, evaluating the pros and cons, comparing the possible sequelae, and then determining a course of action. The more decisions we ask our brain to make, the less able we are to concentrate and make nuanced assessments, and the more our decisions exhibit less insight and forward thinking.8,9 However, rest periods improve task performance. As seen in brain imaging studies, rest allows the brain to continue processing and set up new connections.10 To prevent decision fatigue, plan downtime even if it is for just a few minutes of deep breathing or stretching against the wall every 90 minutes or less. An ideal time is between batches of tasks. Longer reflection time after a meeting is key before the next activity, solidifying the events of the meeting.
I know that on the occasions when I get up in the morning and focus on what is most important to do that day, I generally get it done, as well as other items on my to-do list. If I made prioritizing and planning a deliberate daily habit, it would allow for much greater productivity. It often is recommended that a list be made of all the activities and tasks to be done that day or week and then to compare it to a list of primary goals. Pay attention to the important items and not just the urgent ones. Urgent items can fill up the day but some of them may have little relationship to our primary goals. Those that are urgent but not important can be delegated, deferred, or even purged. Rank the important tasks and schedule the highest priority in defined blocks. This kind of deliberate prioritizing requires repeated monitoring and revisiting of goals and tasks but ensures that what is most important gets done.
Most physicians are perfectionists, which can be a good thing. I want my doctor to be a perfectionist when he/she is examining me or writing me a prescription. But perfectionism also has a high price. It makes delegation of a task difficult because of the perception that the other person might not do the task as well as you can. It also can cause us to put off doing a task because we do not have enough time now to do it well enough. Later we feel stressed because it is still undone, and then we panic and become overwhelmed at the thought of tackling this task, which now has an even bigger emotional load. Being productive means learning to manage procrastination. Brian Tracy has 21 great ways to stop procrastination in his book Eat That Frog,11 but you really only need 3 of his rules: (1) If you have to eat a frog, eat it first thing in the morning. (2) If you have to eat 2 frogs, eat the bigger one first. (3) If the frog is too big to eat, cut it into bite-size pieces.
Will it ever be possible for me to do the same amount of work in less time and feel good about it? I am not sure. However, I have become convinced that I can end each day satisfied with the tasks I was able to accomplish if I develop the habits of single tasking, planning downtime, scheduling priorities, and managing procrastination. I hope these tools will also help you find the same satisfaction.
1. Schor J. The (even more) overworked American. In: de Graaf J, ed. Take Back Your Time: Fighting Overwork and Time Poverty in America. San Francisco, CA: Berrett- Koehler; 2003:7.
2. Virtanen M, Singh-Manoux A, Ferrie JE, et al. Long working hours and cognitive function: the Whitehall II Study. Am J Epidemiol. 2009;169:596-605.
3. Labour productivity levels in the total economy. Organisation for Economic Co-operation and Development website. http://stats.oecd.org/Index.aspx?DatasetCode=LEVEL#. Accessed Feb 17, 2016.
4. Dux PE, Ivanoff J, Asplund CL, et al. Isolation of a central bottleneck of information processing with time-resolved FMRI. Neuron. 2006;52:1109-1120.
5. Iqbal ST, Horvitz E. Disruption and recovery of computing tasks: field study, analysis, and directions. Paper presented at: Computer/Human Interaction 2007 Conference; April 28-May 3, 2007; San Jose, CA.
6. Ophir E, Nass C, Wagner AD. Cognitive control in media multitaskers. Proc Natl Acad Sci U S A. 2009;106:15583-15587.
7. Sanbonmatsu DM, Strayer DL, Medeiros-Ward N, et al. Who multi-tasks and why? multi-tasking ability, perceived multi-tasking ability, impulsivity, and sensation seeking. PLoS One. 2013;8:e54402.
8. Danzinger S, Levav J, Avnaim-Pesso L. Extraneous factors in judicial decisions. Proc Natl Acad Sci U S A. 2011;108:6889-6892.
9. Dai H, Milkman KL, Hofmann DA, et al. The impact of time at work and time off from work on rule compliance: the case of hand hygiene in health care. J Appl Psychol. 2015;100:846-862.
10. Sami S, Robertson EM, Miall RC. The time course of task-specific memory consolidation effects in resting state networks. J Neurosci. 2014;34:3982-3992.
11. Tracy B. Eat That Frog! 21 Ways to Stop Procrastinating and Get More Done in Less Time. 2nd ed. San Francisco, CA: Berrett-Koehler Publishers; 2007.
1. Schor J. The (even more) overworked American. In: de Graaf J, ed. Take Back Your Time: Fighting Overwork and Time Poverty in America. San Francisco, CA: Berrett- Koehler; 2003:7.
2. Virtanen M, Singh-Manoux A, Ferrie JE, et al. Long working hours and cognitive function: the Whitehall II Study. Am J Epidemiol. 2009;169:596-605.
3. Labour productivity levels in the total economy. Organisation for Economic Co-operation and Development website. http://stats.oecd.org/Index.aspx?DatasetCode=LEVEL#. Accessed Feb 17, 2016.
4. Dux PE, Ivanoff J, Asplund CL, et al. Isolation of a central bottleneck of information processing with time-resolved FMRI. Neuron. 2006;52:1109-1120.
5. Iqbal ST, Horvitz E. Disruption and recovery of computing tasks: field study, analysis, and directions. Paper presented at: Computer/Human Interaction 2007 Conference; April 28-May 3, 2007; San Jose, CA.
6. Ophir E, Nass C, Wagner AD. Cognitive control in media multitaskers. Proc Natl Acad Sci U S A. 2009;106:15583-15587.
7. Sanbonmatsu DM, Strayer DL, Medeiros-Ward N, et al. Who multi-tasks and why? multi-tasking ability, perceived multi-tasking ability, impulsivity, and sensation seeking. PLoS One. 2013;8:e54402.
8. Danzinger S, Levav J, Avnaim-Pesso L. Extraneous factors in judicial decisions. Proc Natl Acad Sci U S A. 2011;108:6889-6892.
9. Dai H, Milkman KL, Hofmann DA, et al. The impact of time at work and time off from work on rule compliance: the case of hand hygiene in health care. J Appl Psychol. 2015;100:846-862.
10. Sami S, Robertson EM, Miall RC. The time course of task-specific memory consolidation effects in resting state networks. J Neurosci. 2014;34:3982-3992.
11. Tracy B. Eat That Frog! 21 Ways to Stop Procrastinating and Get More Done in Less Time. 2nd ed. San Francisco, CA: Berrett-Koehler Publishers; 2007.